ANIMAS INSULIN INFUSION PUMP
Report
- Report Number
- 2531779-2013-02431
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PRIME HISTORY REVEALED LARGE PRIMED VOLUME AMOUNTS ON THE REPORTED EVENT DATE. A REVIEW OF THE BLACK BOX HISTORY REVEALED MULTIPLE "OCCLUSION" AND "LOSS OF PRIME" ALARMS DUE ZERO FORCE. THE PUMP WAS FOUND TO POWER ON NORMALLY. DURING A "LOAD" STEP ATTEMPT, THE PISTON WAS FOUND TO STOP SHORT. DURING TESTING, THE PRIME STEP WAS ABLE TO BE PERFORMED ON THE PUMP. AN "OCCLUSION" ALARM WAS DUPLICATED UPON THE FIRST BASAL PROGRAM DELIVERY ATTEMPT. THE PUMP WAS OPENED AND A COMPONENT FROM THE PRINTED CIRCUIT BOARD (PCB) WAS FOUND TO BE MISALIGNED AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. 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.
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT A COMPONENT FROM THE PRINTED CIRCUIT BOARD (PCB) WAS FOUND TO BE MISALIGNED AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95863 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANM 2020 INSULIN INFUSION PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |