ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-27215
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Report Date
- September 10, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/13/2015 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED. A BATTERY COMPARTMENT CRACK WAS OBSERVED. (B)(4).
FOLLOW-UP #1 DATE OF SUBMISSION 10/02/2014-CORRECTION: UPON REVIEW OF THE COMPLAINT ON (B)(4) 2014, THE PRODUCT ON THIS COMPLAINT HAS BEEN CHANGED TO AN INFUSION SET. ANIMAS DOES NOT MANUFACTURE THIS PRODUCT BUT WILL FORWARD THE COMPLAINT TO THE RELEVANT MANUFACTURER.
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.
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY AND A BATTERY COMPARTMENT CRACK. THIS REPORT IS MADE BASED ON RESULTS OF THE INVESTIGATION PERFORMED ON 03/13/2015.
ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) 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 |
|---|---|---|---|---|---|---|---|
| 592124 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |