BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3110015 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01922
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY, STUCK ON THE #2 COUNTDOWN DUE TO A PROBLEM WITH THE MOTHER BOARD. THE DRIVE SUPPORT DISK WAS INSPECTED, AND NO ANOMALY WAS NOTED. UNABLE TO PERFORM THE DISPLACEMENT TEST, OPERATING CURRENTS, BASIC OCCLUSION TEST, OCCLUSION OR EXCESSIVE NO DELIVERY TESTS DUE TO THE FROZEN SCREEN. UNABLE TO VERIFY THE MOTOR ERROR ALARM DUE TO THE FROZEN SCREEN. THE MOTOR PASSED THE MOTOR TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM DURING THE BASAL RATE DELIVERY. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE DISPLACEMENT AND SELF TESTS. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE CUSTOMER LATER CALLED TO REPORT ANOTHER MOTOR ERROR ALARM. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO MULTIPLE MOTOR ERROR ALARMS. THE REPORTED BLOOD GLUCOSE READING WAS 373 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209841 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR