FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2181591
·
Received July 27, 2011
Report
- Report Number
- 2531779-2011-05364
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Report Date
- May 10, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE FORCE SENSOR PLATE WAS PHYSICALLY DAMAGED. THIS REPORT IS BEING MADE BASED ON RESULTS OF INVESTIGATION.
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR MULTIPLE "NO PRIME" WARNINGS. EVALUATION REVEALED THAT THE FORCE SENSOR PLATE WAS PHYSICALLY DAMAGED. THIS REPORT IS BEING MADE BASED ON RESULTS OF INVESTIGATION.
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 | 11 YR |