FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 7315413
·
Received March 5, 2018
Report
- Report Number
- 2531779-2018-04790
- Event Type
- Malfunction
- Date Received
- March 5, 2018
- Report Date
- February 25, 2018
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
THE PUMP 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.
Additional Manufacturer Narrative · 1
DATE OF SUBMISSION (B)(4) 2018: - CORRECTION: BRAND NAME: ANIMAS INSULIN CARTRIDGE - CORRECTION TO: PMA/510 (K) #: K032257
Description of Event or Problem · 1
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE LOSS OF PRIME OCCURRED 2 OR MORE TIMES. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156668 | ANIMAS INSULIN CARTRIDGE | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |