FDA Adverse Event
Malfunction
Summary report: N
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
MDR report key: 1081751
·
Received July 18, 2008
Report
- Report Number
- 3004209178-2008-00522
- Event Type
- Malfunction
- Date Received
- July 18, 2008
- Date of Event
- June 30, 2008
- Report Date
- July 3, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- FMF
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RESERVOIR LEAKED. 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 PUERTO RICO OPERATIONS MED-REL | MMT-326A | WH1407512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |