FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 3CC MMT-332A
MDR report key: 1983798
·
Received January 20, 2011
Report
- Report Number
- 2032227-2011-00182
- Event Type
- Malfunction
- Date Received
- January 20, 2011
- Date of Event
- January 4, 2010
- Report Date
- January 7, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- FRN
- PMA / PMN Number
- K032005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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 NURSE REPORTED THAT INSULIN WAS LEAKING FROM THE RESERVOIR. THE NURSE STATED THAT WHILE THE CUSTOMER WAS TRAVELING, HE FELT REAL SICK AND STOPPED AT THE HOSPITAL WHERE HE WAS ADMITTED FOR HIGH BLOOD GLUCOSE. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESERVOIR 3CC MMT-332A | RESERVOIR | FRN | MEDTRONIC MINIMED | MMT-332A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |