FDA Adverse Event
Malfunction
Summary report: N
MODEL NOT SPECIFIED
MDR report key: 1900054
·
Received November 8, 2010
Report
- Report Number
- 2032227-2010-83126
- Event Type
- Malfunction
- Date Received
- November 8, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 3, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN 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 REPORTED THAT INSULIN LEAKED PAST THE O-RINGS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODEL NOT SPECIFIED | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-XXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |