FDA Adverse Event
Malfunction
Summary report: N
MINILINK TRANSMITTER
MDR report key: 3942845
·
Received July 17, 2014
Report
- Report Number
- 2032227-2014-04452
- Event Type
- Malfunction
- Date Received
- July 17, 2014
- Date of Event
- June 3, 2014
- Report Date
- June 26, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRANSMITTER WAS RECEIVED WITH A BROKEN COW CATCHER AND DAMAGED ON ALL CONTACT PINS. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO BROKEN COW CATCHER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER'S TRANSMITTER WAS NOT WORKING. NO BLOOD GLUCOSE READING WAS GIVEN. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419236 | MINILINK TRANSMITTER | CGM | MDS | MEDTRONIC MINIMED | MMT-7703NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |