FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2130474
·
Received June 16, 2011
Report
- Report Number
- 2531779-2011-04232
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 29, 2011
- Report Date
- April 29, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CORRECTION NUMBER: 2531779-03/24/2010-003-R. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. ADDITIONALLY CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR ASSEMBLY. A REVIEW OF THE PUMP HISTORY SHOWS LOSS OF PRIME WARNINGS. DURING EVALUATION THE PUMP WAS ABLE TO REWIND, LOAD AND PRIME WITH NO ISSUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES.
Description of Event or Problem · 1
THE PUMP WAS RETURNED TO ANIMAS DUE TO MULTIPLE LOSS OF PRIMES. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. ADDITIONALLY CONTAMINATION WAS FOUND ON THE FORCE SENSOR. THIS IS BEING REPORTED BASED ON INVESTIGATION 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 | 61 YR |