FDA Adverse Event
Malfunction
Summary report: N
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
MDR report key: 1024248
·
Received March 27, 2008
Report
- Report Number
- 2032227-2008-00554
- Event Type
- Malfunction
- Date Received
- March 27, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 10, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- FMF
- PMA / PMN Number
- K032005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS STATED THAT THE CUSTOMER EXPERIENCED INSULIN LEAKING FROM THE RESERVOIR INTO THE RESERVOIR COMPARTMENT. THE NURSE STATED THAT THE LEAK OCCURRED ABOUT ONE OR TWO MONTHS AGO, BUT SHE DID NOT HAVE THE EXACT DATE. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSVR MMT-326A 10PK PRDGM 1.8ML 13L | RESERVOIR | FMF | MEDTRONIC MINIMED | MMT-326A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |