FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 3ML
MDR report key: 4153400
·
Received October 8, 2014
Report
- Report Number
- 2032227-2014-35467
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 5, 2014
- Report Date
- September 9, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- FRN
- PMA / PMN Number
- K032005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).
Description of Event or Problem · 1
IT IS REPORTED THAT RESERVOIR LEAKED INSULIN. CUSTOMER'S BLOOD GLUCOSE NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631316 | RESERVOIR 3ML | RESERVOIR | FRN | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-332A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |