ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2013-07485
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Report Date
- May 6, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSTALLED AND DISPLAYED PROPERLY. THE VIBRATION MOTOR WAS NOT RESPONDING DURING TESTING. UNRELATED TO THE DISPLAY AND VIBRATORY MOTOR ISSUE, THE PUMP¿S HISTORY SHOWED MULTIPLE LOW AND REPLACE BATTERY ALARMS, REBOOTS, AND MULTIPLE OCCURRENCES OF A TIME AND DATE RESET TO FACTORY DEFAULT. EVIDENCE OF EXCESSIVE BATTERY USAGE WAS SHOWN IN THE PUMP¿S HISTORY AND INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT. EVIDENCE OF MOISTURE WAS FOUND IN THE PUMP¿S BATTERY COMPARTMENT. DURING INVESTIGATION, THE PUMP¿S INTERNAL BATTERY WAS FOUND TO BE LEAKING. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(6).
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN AND A VIBRATORY MOTOR FAILURE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243134 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |