ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2013-07173
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Report Date
- May 1, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THE DATE THE DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON WAS (B)(6) 2012 AND NOT (B)(6) 2013 AS PREVIOUSLY REPORTED.
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: BLACK BOX REVIEW SHOWS MULTIPLE PERSISTENT REPLACE BATTERY ALARMS ON THE REPORTED FAILURE DATE. THE PUMP BOOTED WITH A LOW BATTERY ALARM AND THE DISPLAY WAS DIM. THE PUMP WAS TESTED WITH AN EXTERNAL POWER SUPPLY AND ALL ACTIVE CURRENTS WERE WELL ABOVE SPECIFICATIONS. BATTERY COMPARTMENT AND CAP ARE INTACT WITH NO DAMAGE OR MOISTURE INGRESS OBSERVED. REPLACE BATTERY ALARM WAS DUPLICATED DURING TESTING. THE PUMP COVER WAS REMOVED, THE POWER FLEX AND POWER CIRCUIT WERE TESTED FOR INTERMITTING CONDITIONS, NO DEFECTS WERE FOUND. A TEST DISPLAY WAS USED FOR TESTING PURPOSES, ALL CURRENT READING RETURNED TO NORMAL SPECIFICATIONS. (B)(6). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS FOUND TO BE DIM. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235507 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |