FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1913806
·
Received November 26, 2010
Report
- Report Number
- 2531779-2010-02571
- Event Type
- Malfunction
- Date Received
- November 26, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 27, 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE IS ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. ANIMAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. A REVIEW OF THE PUMP HISTORY DID NOT OT INDICATE THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. EVALUATION REVEALED PARTIALLY DISLODGED FORCE SENSOR PINS AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.
Description of Event or Problem · 1
DURING EVALUATION, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND THE FORCE SENSOR PINS WERE FOUND TO BE PARTIALLY DISLODGED.
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 | 62 YR |