OneTouch Ping
OneTouch Ping Blood Glucose Management System For self-testing. For Quantitative measurement of glucose in whole blood. For in vitro diagnostic use only
7manufacturers in China registered for this device type
12catalogue numbers in this listing
7510(k) clearances naming this product code
25recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (3), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Animas Corp., United States |
|---|---|
| FDA product code | LZG |
| Device type | Pump, Infusion, Insulin |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| 510(k) | K082590 |
| Record published | 2016-08-18 |
| Record revised | 2021-08-04 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 100 % RH |
| Packaging | Shipper case of 15 |
| Distribution end date | 2020-07-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10143400 | Withdrawn | |
| 10143200 | Withdrawn | |
| 10050000 | Withdrawn | |
| 10543000 | Withdrawn | |
| 10543100 | Withdrawn | |
| 023-049 | Blood Glucose measurement Level mg/dL | Withdrawn |
| 10143100 | Withdrawn | |
| 10543200 | Withdrawn | |
| 10143500 | Withdrawn | |
| 10143000 | Withdrawn | |
| 10543500 | Withdrawn | |
| 10543400 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Easy Release | Sooil Development Co., Ltd. | 9 |
| V-Go Disposable Insulin Delivery | Mannkind Corporation | 6 |
| Accu-Chek Combo | Roche Diabetes Care, Inc. | 5 |
| Superline | Sooil Development Co., Ltd. | 4 |
| t:slim Cartridge, t:lock, 10 Pack | Tandem Diabetes Care, Inc. | 3 |
| Dana Diabecare | Sooil Development Co., Ltd. | 3 |
| Accu-Chek Spirit Cartridge | Roche Diabetes Care, Inc. | 2 |
| t:slim X2 Insulin Pump | Tandem Diabetes Care, Inc. | 2 |
| Omnipod | Insulet Corporation | 2 |
| Soft-Release-ST | Sooil Development Co., Ltd. | 2 |
| t:slim Insulin Pump, Replacement | Tandem Diabetes Care, Inc. | 1 |
| MODD1 Infusion Set, 10 Pack | Modular Medical | 1 |
Showing 12 of 53. All products under Pump, Infusion, Insulin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080639 | 2008-06-24 |
| K063674 | 2007-03-30 |
| K042873 | 2004-12-10 |
| K032257 | 2003-10-16 |
| K022394 | 2003-06-05 |
| K021439 | 2002-05-29 |
| K993184 | 2000-02-10 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-01-03 | Class I | Nonconforming Material/Component | Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: – Loss of prime; -Occlusion | 7,157 (494 US pumps affected) | 2015-05-14 |
| 2012-12-17 | Class III | Device Design | Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display. | 37,998 | 2013-12-24 |
| 2012-10-25 | Class II | Device Design | Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the ma | 1938 | 2015-06-29 |
| 2012-07-16 | Class II | Nonconforming Material/Component | Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump. | 236,470 | 2014-01-15 |
| 2012-03-01 | Not classified | Software design | There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt | 91,239 | 2013-12-24 |
| 2011-07-29 | Not classified | Mixed-up of materials/components | Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a “Replace Battery” alarm not related to the conditi | 380 | 2011-12-07 |
| 2011-02-25 | Not classified | Material/Component Contamination | Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking. | 384,180 | 2014-04-03 |
| 2010-03-18 | Not classified | Equipment maintenance | sensor could be damaged | 2010-10-27 | |
| 2010-03-18 | Not classified | Equipment maintenance | sensor could be damaged | 2010-10-27 | |
| 2010-03-18 | Not classified | Equipment maintenance | sensor could be damaged | 2010-10-27 | |
| 2010-03-18 | Not classified | Equipment maintenance | sensor could be damaged | 2010-10-27 | |
| 2009-12-18 | Not classified | Software design | Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food dat | 21 pumps | 2010-06-22 |
| 2008-10-27 | Not classified | Software design | incorrect dosing recommendation | 5093 units | 2009-12-15 |
| 2008-08-04 | Not classified | Nonconforming Material/Component | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure | 990 units | 2010-02-04 |
| 2008-08-04 | Not classified | Nonconforming Material/Component | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure | 251 units | 2010-02-04 |
| 2008-08-04 | Not classified | Nonconforming Material/Component | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure | 1,388 caps | 2010-02-04 |
| 2008-08-04 | Not classified | Nonconforming Material/Component | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure | 1,624 units | 2010-02-04 |
| 2008-08-04 | Not classified | Nonconforming Material/Component | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure | 2,899 units | 2010-02-04 |
| 2008-08-04 | Not classified | Software design | display old, inaccurate values for bolus amount delivered and amount of planned bolus totals | 251 units | 2008-11-12 |
| 2005-10-31 | Not classified | Other | Pumps were refurbished more than one time for the same failure mode in violation of the company’s procedure. | 2 units | 2005-12-23 |
| 2005-10-31 | Not classified | Other | Pumps were refurbished more than one time for the same failure mode in violation of the company’s procedure. | 22 units | 2005-12-23 |
| 2005-10-31 | Not classified | Other | Pumps were refurbished more than one time for the same failure mode in violation of the company’s procedure. | 2 units | 2005-12-23 |
| 2005-10-31 | Not classified | Other | Pumps were refurbished more than one time for the same failure mode in violation of the company’s procedure. | 6 units | 2005-12-23 |
| 2005-04-11 | Not classified | Other | pump failed to respond to keypad button pressess after using the food database feature | 2081 units | 2006-01-24 |
| 2004-09-28 | Not classified | Other | Suspend mode not functioning properly | 7395 units | 2005-03-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.