FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2875138
·
Received December 17, 2012
Report
- Report Number
- 2531779-2012-14624
- Event Type
- Malfunction
- Date Received
- December 17, 2012
- Report Date
- November 24, 2012
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
ON (B)(6) 2012 THE PATIENT CONTACTED ANIMAS ALLEGING THAT HE EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) UP TO 413MG/DL WITH DRY MOUTH DUE TO A LEAKING CARTRIDGE. THE PATIENT REPORTEDLY TREATED ELEVATED BGS WITH CORRECTION INJECTIONS AND CHANGED SUPPLIES. THE PATIENT WAS UNSURE IF THE INSULIN WAS LEAKING AT THE LUER CONNECTION OR FROM THE PLUNGER END OF THE CARTRIDGE. THE REPORTED BG EXCURSION DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGATION THAT THE CARTRIDGE WAS LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN CARTRIDGE | INSULIN PUMP CARTRIDGE | LZG | ANIMAS CORPORATION | ANM IR1200/1250/2020/OTP CART |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |