FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 1.8 ML
MDR report key: 2222025
·
Received August 17, 2011
Report
- Report Number
- 3004209178-2011-82586
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 6, 2011
- Report Date
- August 6, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- FRN
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 INSULIN WAS LEAKING FROM THE RESERVOIR. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESERVOIR 1.8 ML | RESERVOIR | FRN | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-326A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |