FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2050595
·
Received March 15, 2011
Report
- Report Number
- 2531779-2011-01601
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 16, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS. DURING EVALUATION THE PUMP BOOTED TO AN AUDIBLE ALARM AND AN EPROM FAILURE OCCURRED. THE EPROM FAILURE STILL PERSISTED AFTER THE INVESTIGATOR ATTEMPTED TO UPLOAD SOFTWARE FILES. THE PUMP COULD NOT BE DOWNLOADED DUE TO A SOFTWARE CORRUPTION.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT THE PUMP DID NOT START.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |