FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 5352588
·
Received January 7, 2016
Report
- Report Number
- 2531779-2016-00750
- Event Type
- Malfunction
- Date Received
- January 7, 2016
- Report Date
- December 15, 2015
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/15/2015 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED BELOW THE BUMPER PAD. UNRELATED TO THIS ISSUE, THE PUMP¿S LOW PROFILE CLIP WAS FOUND TO BE DAMAGED. (B)(6)
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/15/2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10686 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |