ANIMAS INSULIN INFUSION PUMP
Report
- Report Number
- 2531779-2013-00897
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Report Date
- January 14, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.
(B)(4).
FOLLOW-UP #1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE OK AND UP KEYPAD SYMBOLS WERE WORN AND THE KEYPAD WAS PEELING NEAR THE BOTTOM OF THE OK KEY. ALL BUTTONS RESPONDED APPROPRIATELY. EVALUATION REVEALED THERE WAS CONTAMINATION UNDER THE CONTRAST KEY. UNRELATED TO THE COMPLAINT EVALUATION REVEALED THE DISPLAY LENS WAS CRACKED, WHICH HAS NO EFFECT ON INSULIN DELIVERY.
THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE KEYPAD BUTTONS WERE LOCKING IN THEIR OWN WITHOUT BUTTON PRESSES. THE REPORTER STATED THAT THE KEYPAD IS PEELING NEAR THE OK BUTTON. THE PATIENT REPORTEDLY WORE THE PUMP UNDER A GARMENT AND DOES NOT CLEAN THE PUMP. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE KEYPAD RESPONSE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30789 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANM 2020 INSULIN INFUSION PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |