FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2180626
·
Received July 27, 2011
Report
- Report Number
- 2531779-2011-05350
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Report Date
- June 27, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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
THE PATIENT REPORTED THAT AIR BUBBLES OCCUR WHEN THE PUMP IS BELOW THE TUBING. THE PATIENT REPORTS HAVING LOW BLOOD SUGARS (IN THE 50 MG/DL RANGE). THIS DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS BEING MADE BASED ON THE ALLEGATION OF AIR BUBBLES.
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 | 26 YR |