BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3934351 · Received July 15, 2014

    Report

    Report Number
    2032227-2014-03597
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP IS CONSTANTLY BEEPING. CUSTOMER IS HOSPITALIZED DUE TO TRIPLE BYPASS SURGERY. HOSPITALIZATION NOT DIABETES RELATED. CUSTOMER WANTS TO TURN THE SOUND OFF. ASSISTED CUSTOMER WITH SETTING THE BASAL RATES TO ZERO. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412047 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7707NA A000295477

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR