ANIMAS INSULIN CARTRIDGE
Report
- Report Number
- 2531779-2013-03780
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Report Date
- March 14, 2013
- 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
FOLLOW-UP # 1 DATE OF SUBMISSION 06/11/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DISPLAY WAS FOUND TO BE DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST SCREEN FOR TESTING AND WAS FOUND TO FUNCTION PROPERLY. UNRELATED TO THE DISPLAY ISSUE, EVALUATION REVEALED THAT THE CARTRIDGE COMPARTMENT WAS CRACKED AT THE THREADS.
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE DISPLAY SCREEN WAS DIM AND FADING. THE REPORTER NOTED EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143232 | ANIMAS INSULIN CARTRIDGE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |