FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2050590
·
Received March 15, 2011
Report
- Report Number
- 2531779-2011-01612
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 12, 2011
- Report Date
- February 12, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: INVESTIGATOR CONFIRMED ISSUE IN HISTORY BUT WAS NOT ABLE TO REPRODUCE DURING INVESTIGATION.
Description of Event or Problem · 1
THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. HOWEVER, THE REPORTER CLAIMED THAT THE ANIMAS INSULIN PUMP SELF REBOOTED ON THREE OCCASIONS, WHICH RESULTED IN LOSS OF PRIME AND NO INSULIN WAS DELIVERED AT THE TIME OF CONCERN. HENCE, THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED SYSTEM FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ONE TOUCH PING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |