ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-15312
- Event Type
- Malfunction
- Date Received
- May 31, 2014
- Report Date
- May 26, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
FOLLOW-UP # 1 DATE OF SUBMISSION 07/01/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/26/2014 WITH THE FOLLOWING FINDINGS:DURING A VISUAL INSPECTION OF THE PUMP, MOISTURE WAS VISIBLE BEHIND THE DISPLAY LENS. NO DAMAGE WAS OBSERVED TO THE PUMP BATTERY COMPARTMENT, AND THE BATTERY CAP SECURED PROPERLY. THE PUMP CASING WAS OBSERVED TO BE CRACKED IN THE UPPER RIGHT CORNER NEAR THE DISPLAY. DURING TESTING, THE PUMP POWERED ON WITH AUDIBLE TONES, NO VIBRATION, AND A BLANK DISPLAY. A LEAK TEST WAS PERFORMED AND CONFIRMED A LEAK AT THE CRACK IN THE PUMP CASING. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE INGRESS WAS FOUND THROUGHOUT THE PUMP INTERIOR.
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT THE PUMP LOST POWER. MOISTURE WAS ALLEGEDLY VISIBLE BEHIND THE PUMP DISPLAY LENS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320520 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |