FDA Adverse Event
Death
Summary report: N
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
MDR report key: 1667341
·
Received April 19, 2010
Report
- Report Number
- 2032227-2010-80946
- Event Type
- Death
- Date Received
- April 19, 2010
- Date of Event
- January 11, 2010
- Report Date
- April 1, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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
THE CUSTOMER'S FATHER REPORTED THAT THE CUSTOMER PASSED AWAY AFTER SUFFERING A HYPOGLYCEMIC CEREBRAL INJURY. THE FATHER STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP WHEN HE WAS FOUND. THE MOTHER KEPT THE INSULIN PUMP, AND THE FATHER HAS NO COMMUNICATION WITH HER. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAB PRDGM INS V2.2 BL EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-722NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization |