FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 3ML
MDR report key: 3260537
·
Received August 1, 2013
Report
- Report Number
- 3004209178-2013-96383
- Event Type
- Malfunction
- Date Received
- August 1, 2013
- Date of Event
- July 5, 2013
- Report Date
- July 26, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- FRN
- PMA / PMN Number
- K032005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
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. PLEASE SEE MEDWATCH REPORT # 3004209178-2013-96382.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE RESERVOIR AND TUBING CONNECTION WAS REALLY WOBBLY, AND WHEN SHE REMOVED THE CAP INSULIN WAS FOUND INSIDE THE RESERVOIR COMPARTMENT. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360496 | RESERVOIR 3ML | RESERVOIR | FRN | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-332A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |