FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2032314
·
Received March 23, 2011
Report
- Report Number
- 2531779-2011-01858
- Event Type
- Injury
- Date Received
- March 23, 2011
- Report Date
- February 22, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Removal / Correction Number
- 2531779-02/25/11-001-R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 REPORTED THE INSULIN CARTRIDGE WAS LEAKING INTO THE PUMP'S CARTRIDGE COMPARTMENT, AND THE PT OBTAINED A BLOOD GLUCOSE LEVEL OF 360 MG/DL WITH POSITIVE KETONES. THE PT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PT TOOK AN INSULIN BOLUS USING A SYRINGE, CHANGED THE INFUSION SITE AND CARTRIDGE, AND HIS BLOOD GLUCOSE LEVELS RETURNED TO NORMAL, 90 MG/DL TO 140 MG/DL. THE PT DID NOT SEEK ANY MEDICAL ATTENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN CARTRIDGE | INSULIN INFUSION PUMP CARTRIDGE | LZG | ANIMAS CORPORATION | IR 1200 / 1250 / 2020 / OTP | B201575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |