FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2076507
·
Received April 1, 2011
Report
- Report Number
- 2531779-2011-01979
- Event Type
- Malfunction
- Date Received
- April 1, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 23, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. THE REPORTED LOT # WERE CONFIRMED TO BE DEFECTIVE WITH THE RETAINS. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.
Description of Event or Problem · 1
THE REPORTER CLAIMED THAT HIS INSULIN CARTRIDGE WITH LOT# B201583 LEAKS. REPORTEDLY HIS BLOOD GLUCOSE WAS HIGHER THAN USUAL WHEN THE EVENT OCCURRED. HOWEVER, THERE WAS NO REPORT OF ANY SYMPTOMS AND MEDICATION INTERVENTION THAT WOULD SUGGEST ANY ACUTE COMPLICATION OF DIABETES.
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 | B201583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |