FDA Adverse Event
Malfunction
Summary report: N
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
MDR report key: 1070943
·
Received July 3, 2008
Report
- Report Number
- 2032227-2008-01142
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 30, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- FMF
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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 THE INSULIN LEAKED OUT OF THE RESERVOIR. THE BLOOD GLUCOSE READING WAS NOT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSVR MMT-326A 10PK PRDGM 1.8ML 13L | DISPOSABLES | FMF | MEDTRONIC MINIMED | MMT-326A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |