FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3854967
·
Received June 9, 2014
Report
- Report Number
- 2531779-2014-16102
- Event Type
- Malfunction
- Date Received
- June 9, 2014
- Report Date
- May 22, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS WITH RETURNED BATTERY CAP. BATTERY CAP IS UNABLE TO FULLY TIGHTEN. BATTERY COMPARTMENT THREADS DAMAGED. A POWER LOSS WAS NOT OBSERVED. BATTERY CAP IS ABLE TO BE REMOVED WITHOUT DIFFICULTY. BATTER CAP THREADS INTACT. BATTERY CAP IS ABLE TO FULLY TIGHTEN ON A TEST PUMP. NO DAMAGE TO BATTERY CAP OBSERVED. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED BATTERY COMPARTMENT THREADS ARE DAMAGED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336567 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |