FDA Adverse Event
Death
Summary report: N
PUMP MMT-722LNAB PRDGM INS BL EN ML
MDR report key: 1063276
·
Received June 18, 2008
Report
- Report Number
- 2032227-2008-01008
- Event Type
- Death
- Date Received
- June 18, 2008
- Date of Event
- March 27, 2008
- Report Date
- June 3, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- P980022
- 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 AFTER EXPERIENCING DIABETIC KETOACIDOSIS. IT WAS STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722LNAB PRDGM INS BL EN ML | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-722LNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |