BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4170089 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37777
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRANSMITTER WAS UNABLE TO CHARGE DUE TO A DAMAGED COW CATCHER AND DAMAGE TO ALL CONTACT PINS. THE FUNCTIONAL TESTS COULD NOT BE PERFORMED DUE TO THE CHARGE ANOMALY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS SENDING BACK THE TRANSMITTER. NO BLOOD GLUCOSE READING WAS GIVEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649472 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR