FDA Adverse Event
Death
Summary report: N
PUMP MMT-522LNAL PRDGM INS CL EN ML
MDR report key: 1726188
·
Received June 11, 2010
Report
- Report Number
- 2032227-2010-81451
- Event Type
- Death
- Date Received
- June 11, 2010
- Date of Event
- May 6, 2010
- Report Date
- May 20, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 DIABETES COMPLICATIONS. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP IS GOING TO BE DONATED PER THE FAMILY. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522LNAL PRDGM INS CL EN ML | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-522LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death |