BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984123 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91506
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH CONSTANT TONE AND FROZEN SCREEN AS A RESULT OF A FAULTY COMPONENT ON THE MOTHERBOARD. UNABLE TO CONFIRM THE BUTTON/KEYPAD ANOMALY DUE TO THE FROZEN SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A CONSTANT TONE. THE BLOOD GLUCOSE READING WAS 312MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE BUTTONS WERE UNRESPONSIVE. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85992 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR