ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-13600
- Event Type
- Malfunction
- Date Received
- May 15, 2014
- Report Date
- May 5, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
(B)(4). 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 SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA DID NOT FIND ANY RELATED WARNINGS. THE PUMP POWERED UP WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. SIMULATED ALARMS WERE PROPERLY DISPLAYED WITH THE CORRECT AUDIBLE OR VIBRATORY FEATURES. THE INVESTIGATION WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED ALARM FAILURE ISSUE. UNRELATED TO THE REPORTED ALARM ISSUE, IT WAS OBSERVED THAT THE VERIFY SCREEN WAS DISCOLORED.
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 AUDIO TONE/VIBRATION (DUAL ALARM FAILURE) ISSUE. REPORTEDLY, BOTH THE AUDIBLE AND VIBRATORY FEATURES WERE NOT WORKING. 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 |
|---|---|---|---|---|---|---|---|
| 292055 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |