FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2067156
·
Received April 13, 2011
Report
- Report Number
- 2531779-2011-02508
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 3, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Removal / Correction Number
- 2531779-02/25/11-001-R
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH, THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201575 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.
Description of Event or Problem · 1
IT WAS ALLEGED THAT THE PT EXPERIENCED HYPERGLYCEMIA AS THE RESULT OF INSULIN LEAKAGE FROM THE CARTRIDGE. THE PT'S BLOOD GLUCOSE LEVEL INCREASED TO 500MG/DL WITH HEADACHE, NAUSEA AND KETONES.
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 | B201575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |