FDA Adverse Event
Death
Summary report: N
PUMP MMT-712LNAB PRDGM INS BL EN US LN
MDR report key: 1000525
·
Received February 21, 2008
Report
- Report Number
- 2032227-2008-00363
- Event Type
- Death
- Date Received
- February 21, 2008
- Date of Event
- December 2, 2007
- Report Date
- February 6, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K031390
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS STATED THAT THE CUSTOMER PASSED AWAY DUE TO A HEART ATTACK. THE CUSTOMER WAS TAKEN TO THE HOSPITAL PRIOR TO HIS DEATH FOR DIABETIC KETOACIDOSIS AND BLOOD GLUCOSE LEVELS IN THE 500 MG/DL RANGE. IT WAS STATED THAT THE CUSTOMER HAD BEEN IN AND OUT OF THE HOSPITAL FOR HIGH AND LOW BLOOD GLUCOSE LEVELS. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-712LNAB PRDGM INS BL EN US LN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-712LNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |