FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 3ML
MDR report key: 4241858
·
Received November 10, 2014
Report
- Report Number
- 2032227-2014-50165
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- October 11, 2014
- Report Date
- October 13, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- FRN
- PMA / PMN Number
- K032005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE PRODUCT WAS NOT RETURNED. NOTHING FURTHER TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724133 | RESERVOIR 3ML | RESERVOIR | FRN | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-332A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |