FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3294532
·
Received August 19, 2013
Report
- Report Number
- 2531779-2013-13137
- Event Type
- Malfunction
- Date Received
- August 19, 2013
- Report Date
- July 25, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THERE WERE MULTIPLE REPLACE BATTERY ALARMS IN THE BLACK BOX. THE BATTERY COMPARTMENT WAS INTACT. THERE WAS NO MOISTURE CONTAMINATION INSIDE THE BATTERY COMPARTMENT AND THE BATTERY CAP IS ABLE TO FULLY TIGHTEN. A POWER LOSS WAS NOT OBSERVED. CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THERE WAS MOISTURE CONTAMINATION IDENTIFIED INSIDE THE PUMP. THE DISPLAY IS FADED, DISCOLORED AND DIFFICULT TO READ. AND THE DISPLAY LENS WAS SCRATCHED. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS FADED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 07/25/2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399807 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |