BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4170105 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37769
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRANSMITTER WAS UNABLE TO CHARGE DUE TO A BROKEN COW CATCHER AND DAMAGE TO ALL CONTACT PINS. THE FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO CHARGE ANOMALY. THE TRANSMITTER WAS RECEIVED WITH A BROKEN CASE AT THE TEST PLUG CONNECTOR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TRANSMITTER WAS BROKEN. HE STATED THAT THE CONNECTION BRIDGE WAS DAMAGED AND THAT ONE OF THE PRONGS WAS BENT. NO BLOOD GLUCOSE READING WAS GIVEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649871 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR