FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2083602
·
Received May 10, 2011
Report
- Report Number
- 2531779-2011-03307
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Report Date
- April 13, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
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 DRAWN AT THIS TIME. RETAIN CARTRIDGES OF THE SAME LOT # B201457 WERE TESTED AND PASSED TESTING WITH NO DEFECT FOUND. NO LEAKS OR FAILURES WERE OBSERVED ON THE CARTRIDGES.
Description of Event or Problem · 1
THE REPORTER, THE PATIENT'S MOTHER, REPORTED THE INSULIN CARTRIDGES WERE LEAKING INTO THE CARTRIDGE COMPARTMENT. TROUBLESHOOTING REVEALED THERE WERE NO CRACKS IN THE INSULIN CARTRIDGE AND THE PATIENT'S TECHNIQUE WAS CORRECT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANM IR1200/1250/2020/OTP CART | B201457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |