FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3801458
·
Received May 8, 2014
Report
- Report Number
- 2531779-2014-13086
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Report Date
- May 2, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/02/2014 WITH THE FOLLOWING FINDINGS:EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/02/2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277404 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |