ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-26397
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Report Date
- September 3, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT
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.
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON, AS CONFIRMED BY THE PRESENCE OF THE AUDITORY AND VIBRATORY CUES; HOWEVER, THE DISPLAY SCREEN WAS BLANK. THE REPORTED BLANK-DISPLAY ISSUE WAS DUPLICATED. THE PUMP CASE WAS REMOVED, AND THE DISPLAY SCREEN WAS FOUND TO BE CRACKED; THIS DEVICE FAILURE DIRECTLY CAUSED THE REPORTED BLANK-DISPLAY ISSUE. THE SUSPECT DISPLAY SCREEN WAS REPLACED WITH A TEST DISPLAY SCREEN; THE PUMP DISPLAY FUNCTIONED PROPERLY WITH THE TEST DISPLAY SCREEN INSTALLED.
ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. IT WAS REPORTED THAT THE PUMP DISPLAY SCREEN WAS BLANK. 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 |
|---|---|---|---|---|---|---|---|
| 571192 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |