BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3993967 · Received August 8, 2014

    Report

    Report Number
    2032227-2014-06751
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM NOTED. THE DEVICE HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE DEVICE HAD CRACKED RESERVOIR TUBE.THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. THE ALARM WAS EXPLAINED TO THE CUSTOMER. THE DEVICE WAS EXPOSED TO SWEAT. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469116 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWH

    Patients

    Seq Age Sex Outcome Treatment
    1