FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2810063
·
Received October 31, 2012
Report
- Report Number
- 2531779-2012-12941
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Report Date
- October 4, 2012
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR ASSEMBLY. DURING EVALUATION THE PUMP WAS ABLE TO REWIND, AND LOAD SUCCESSFULLY. THE PUMP LOST PRIME FOLLOWING THE PRIME STEP.
Description of Event or Problem · 1
THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. 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 | 38 YR |