BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN REAL-TIME MONITIOR

    MDR report key: 3980715 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-05948
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BUTTON ERROR ALARM. THERE WAS NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP WAS RECEIVED WITH SCRATCHED LCD WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 136 MG/DL. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457917 GUARDIAN REAL-TIME MONITIOR CGM MDS MEDTRONIC MINIMED CSS7100NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR