BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3945527 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04559
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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. 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 TRANSMITTER HAD MOISTURE DAMAGE ON ALL CONTACT PINS. HOWEVER, THE TRANSMITTER PASSED ALL FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TRANSMITTER FELL OFF IN THE SHOWER AND AFTER THAT HE HAS BEEN RECEIVING SENSOR ERROR ALERT WHEN CONNECTING THE TRANSMITTER TO THE SENSOR. CUSTOMER WAS ADVISED THAT MOISTURE INSIDE THE TRANSMITTER COULD CAUSE MALFUNCTION. BLOOD GLUCOSE 99 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424368 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA A000310845

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR