BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 2870056 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-07991
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    CGA
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 ALSO MFR REPORT NUMBER 2032227-2012-07992.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED ON (B)(6) 2012 TO REPORT THAT SHE WANTED TO TEST THE TRANSMITTER TO ENSURE THAT IT WAS FUNCTIONING PROPERLY. TROUBLESHOOTING WAS PERFORMED, BUT THE GREEN LIGHT DID NOT BLINK WHEN CONNECTED TO THE TEST PLUG. HOWEVER IT DID BLINK WHEN CONNECTED TO THE CHARGER. ADVISED THE CUSTOMER THAT A TEST PLUG WOULD BE SENT TO HER FOR FURTHER TESTING. THE CUSTOMER CALLED BACK ON (B)(6) 2012 TO TRACK THE DELIVERY OF THE TEST PLUG. THE CUSTOMER THEN STATED THAT SHE RELIES HEAVILY ON THE SENSOR BECAUSE, SHE WAS HOSPITALIZED ON (B)(6) 2012 DUE TO LOW BLOOD GLUCOSE LEVELS BECAUSE HER TRANSMITTER AND SENSOR WERE NOT WORKING PROPERLY. ADVISED THE CUSTOMER THAT THE PACKAGE WOULD BE ARRIVING TODAY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILINK TRANSMITTER MDS CGA MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization