FDA Adverse Event
Injury
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3072797
·
Received April 23, 2013
Report
- Report Number
- 2531779-2013-04900
- Event Type
- Injury
- Date Received
- April 23, 2013
- Report Date
- March 25, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
ANIMAS CONTACTED THE PATIENT ON (B)(6) 2013 AND THE WIFE ANSWERED. THE WIFE STATED THAT (HER HUSBAND) THE PATIENT WAS IN THE HOSPITAL AND SHE WAS NOT SURE WHEN HE WOULD BE GETTING OUT. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173626 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization |