ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-27508
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Report Date
- September 13, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 AND EVALUATED BY PRODUCT ANALYSIS ON 11/15/2014.
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/14/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A CS 064 CALL SERVICE ALARM AND A CS 078 CALL SERVICE ALARM. DURING TESTING, THE REWIND STEP WAS ATTEMPTED, AND THE PUMP EMITTED A CS 128-FE88 CALL SERVICE ALARM. FURTHER INVESTIGATION OF THE ALLEGED CS 064 COMPLAINT COULD NOT BE COMPLETED DUE TO THE EMITTED ALARM ON EVERY ATTEMPT AT THE REWIND STEP.
ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED A CS 064 CALL SERVICE ALARM DURING THE REWIND/LOAD STEPS. 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 |
|---|---|---|---|---|---|---|---|
| 601752 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |