FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2925170
·
Received January 22, 2013
Report
- Report Number
- 2531779-2013-00993
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- October 25, 2012
- Report Date
- December 27, 2012
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP # 1 (B)(4) 2013. THE PRODUCT WAS INVESTIGATED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX HISTORY REVEALED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. DURING THE LOAD CARTRIDGE STEP, THE PUMP FAILED TO DETECT THE CARTRIDGE. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS OPENED AND A FORCE SENSOR CIRCUIT COMPONENT WAS FOUND TO BE DISLODGE ON THE PRINTED CIRCUIT BOARD. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR RECURRING LOSS OF PRIME WARNINGS. INVESTIGATION FOUND THAT A DISLODGE FORCE SENSOR CIRCUIT COMPONENT AND AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30773 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANM 2020 INSULIN INFUSION PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |