FDA Adverse Event
Death
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1692326
·
Received May 13, 2010
Report
- Report Number
- 2531779-2010-00249
- Event Type
- Death
- Date Received
- May 13, 2010
- Date of Event
- September 16, 2009
- Report Date
- April 12, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE AUTOPSY REPORT LISTED THE MANNER OF DEATH AS "NATURAL". THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PASSED AWAY FROM UNK CAUSE. THE AUTOPSY REPORT WAS SUBSEQUENTLY REC'D AND INDICATED THAT THE CAUSE OF DEATH WAS "DIABETIC KETOACIDOSIS, WITH MYOCARDIAL ISCHEMIA AS CONTRIBUTORY CONDITION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ONE TOUCH PING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |