FDA Adverse Event
Malfunction
Summary report: N
MINILINK TRANSMITTER
MDR report key: 3954145
·
Received July 23, 2014
Report
- Report Number
- 2032227-2014-04681
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 13, 2014
- Report Date
- July 21, 2016
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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.
Additional Manufacturer Narrative · 1
THE MINILINK TRANSMITTER WAS RECEIVED UNABLE TO CHARGE DUE TO BROKEN CONTACT PIN #5; UNABLE TO PERFORM FUNCTIONAL TESTING DUE TO CHARGE ANOMALY. THE MINILINK TRANSMITTER HAD CONTAMINATION ALL CONTACT PINS.
Description of Event or Problem · 1
IT WAS REPORTED THE TRANSMITTER LIGHT DOES NOT TURN ON AND OFF. NO BLOOD GLUCOSE NOTED. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430017 | MINILINK TRANSMITTER | CGM | MDS | MEDTRONIC MINIMED | MMT-7703NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 114 YR |