FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2027637
·
Received March 17, 2011
Report
- Report Number
- 2531779-2011-01733
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- December 22, 2010
- Report Date
- February 15, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Removal / Correction Number
- 2531779-02/25/11-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE WAS NOT RETURNED TO ANIMAS; THE CARTRIDGE LOT NUMBER WAS NOT PROVIDED. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # B201575, B201576, B201581, B201582, B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.
Description of Event or Problem · 1
THE RPTR, THE PT'S PHYSICIAN, REPORTED THE PT HAD A 'DEFECTIVE' CARTRIDGE USED WITH THE INSULIN PUMP IN (B)(6) 2010 AND (B)(6) 2011. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN CARTRIDGE | INSULIN INFUSION PUMP CARTRIDGE | LZG | ANIMAS CORP. | IR 1200 / 1250 / 2020 / OTP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |