FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1902997
·
Received November 12, 2010
Report
- Report Number
- 2531779-2010-02266
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 14, 2010
- Report Date
- October 14, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Removal / Correction Number
- 2531779-03/24/2010/003-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP. THE PATIENT REBOOTED THE PUMP TWICE AND ON THE THIRD ATTEMPT AT PRIMING, WAS ABLE TO COMPLETE THE LOAD STEP AND PRIME THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | IR 1250 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |