ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-16306
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Report Date
- June 3, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
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.
FOLLOW-UP #1: DATE OF SUBMISSION 07/08/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND NO COSMETIC DAMAGES. THE PUMP POWERED ON AND FUNCTIONED PROPERLY. THE DISPLAY HAD A NORMAL CONTRAST WITH NO LINES THROUGH THE DISPLAY. THE INVESTIGATION WAS UNABLE TO DUPLICATE THE REPORTED DISPLAY ISSUE.
ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (LINE THROUGH DISPLAY) ISSUE. REPORTEDLY, THERE WAS A LINE THROUGH THE DISPLAY AND THE REPORTER WAS UNABLE TO READ/MANEUVER THE SCREENS SAFELY. IT WAS REPORTED THAT THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP AND CONTRAST RESET DID NOT RESOLVE THE ISSUE. 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 |
|---|---|---|---|---|---|---|---|
| 338178 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |