FDA Adverse Event
Malfunction
Summary report: N
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
MDR report key: 1212701
·
Received October 22, 2008
Report
- Report Number
- 2032227-2008-01816
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 8, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- FMF
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT INSULIN LEAKED FROM THE RESERVOIR INTO THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSVR MMT-326A 10PK PRDGM 1.8ML 13L | DISPOSABLE | FMF | MEDTRONIC MINIMED | MMT-326A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |