FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3943627
·
Received July 18, 2014
Report
- Report Number
- 2531779-2014-20593
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Report Date
- July 9, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/09/2014 WITH THE FOLLOWING FINDINGS:DURING TESTING, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. UNRELATED TO THE DISPLAY ISSUE, TESTING REVEALED THE TIME AND DATE RESET TO FACTORY SETTINGS. THE PUMP CASE WAS REMOVED AND EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE CIRCUIT BOARD HAD FAILED. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY FAILURE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 07/09/2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422412 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |