FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2033443
·
Received March 23, 2011
Report
- Report Number
- 2531779-2011-01852
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Report Date
- February 22, 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
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201576 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 REPORTER REPORTED, THE INSULIN CARTRIDGE WAS LEAKING INTO THE PUMP CARTRIDGE COMPARTMENT. THE PT OBTAINED BLOOD GLUCOSE READINGS 'IN THE 200'S MG/DL', BUT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS AND DID NOT SEEK MEDICAL ATTENTION. 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 | B201576 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |