FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2033419
·
Received March 23, 2011
Report
- Report Number
- 2531779-2011-01821
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 7, 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
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201581 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, THE PT'S MOTHER, REPORTED THE INSULIN CARTRIDGE WAS FOUND LEAKING. ON (B)(6), 2011, THE PT OBTAINED AN ELEVATED BLOOD GLUCOSE READING OF 471 MG/DL. AT THAT TIME, THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. AND DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PT CORRECTED HER BLOOD GLUCOSE LEVELS USING A SYRINGE AND REPLACED THE INSULIN CARTRIDGE.
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 | B201581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |