FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2162281
·
Received July 14, 2011
Report
- Report Number
- 2531779-2011-04948
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- April 13, 2011
- Report Date
- April 13, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON 06/17/2011. RECALL 2531779-03/24/2010-003-R. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE DIMPLED AND OUT OF CALIBRATION. CONTAMINATION WAS FOUND ON THE FORCE SENSOR ASSEMBLY. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED.
Description of Event or Problem · 1
PUMP IS RETURNED FOR MULTIPLE LOSS OF PRIME ALARMS. EVALUATION REVEALED AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONETOUCH PING INSULIN PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 |