FDA Adverse Event
Death
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 6177667
·
Received December 15, 2016
Report
- Report Number
- 2531779-2016-33796
- Event Type
- Death
- Date Received
- December 15, 2016
- Date of Event
- June 27, 2015
- Report Date
- December 5, 2016
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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
ON (B)(6) 2016, THE PATIENT¿S WIFE CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2015. THE PATIENT¿S WIFE STATED THAT THE PATIENT HAD PURPOSEFULLY OVERDOSED ON THE INSULIN PUMP. THE PATIENT¿S WIFE COULD NOT BE REACHED FOR FURTHER INFORMATION. THERE WAS NO EVIDENCE THAT THE PUMP HAD MALFUNCTIONED IN ANY WAY BASED ON THE INFORMATION PROVIDED BY THE REPORTER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY PASSED AWAY WHILE WEARING THE INSULIN PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 829757 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |