FDA Adverse Event
Death
Summary report: N
PUMP MMT-722LNAP PRDGM INS PL EN ML
MDR report key: 1696114
·
Received May 19, 2010
Report
- Report Number
- 2032227-2010-81244
- Event Type
- Death
- Date Received
- May 19, 2010
- Date of Event
- March 10, 2009
- Report Date
- April 29, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
IT WAS STATED THAT THE CUSTOMER PASSED AWAY DUE TO DIABETIC KETOACIDOSIS. IT WAS STATED THAT THE INSULIN PUMP DELIVERED INSUFFICIENT INSULIN, LEADING TO THE CUSTOMER'S DEATH. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722LNAP PRDGM INS PL EN ML | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-722LNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Death |