FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2033433
·
Received March 23, 2011
Report
- Report Number
- 2531779-2011-01880
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 23, 2011
- Manufacturer
- ANIMAS CORPORATION
- 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
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE WAS RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # 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 PT STATED THAT SHE NOTICED THE ODOR OF INSULIN WHEN REMOVING THE CARTRIDGE. SHE REPORTS SHE SAW SLIGHT MOISTURE IN THE CARTRIDGE COMPARTMENT OF THE PUMP. SHE DENIES THAT HER BLOOD GLUCOSE LEVELS HAVE BEEN OUT OF THE USUAL RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN CARTRIDGE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | IR 1200 / 1250 / 2020 / OTP | B201583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |