FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2852283
·
Received November 30, 2012
Report
- Report Number
- 2531779-2012-14101
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Report Date
- November 19, 2012
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE 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.
Description of Event or Problem · 1
THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE CARTRIDGES WERE DEFECTIVE. THERE IS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE DEFECTIVE CARTRIDGE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN CARTRIDGE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANM IR1200/1250/2020/OTP CART |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |