BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3945613 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04535
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUTTON ERROR ON HER INSULIN PUMP. THE CUSTOMER STATED THAT SHE CLEARED THE ALARM, BUT THEN THE BUTTONS WERE STICKING AND THE NUMBERS ON THE SCREEN WERE RAMPING UP ON THEIR OWN. HER BLOOD GLUCOSE LEVEL WAS 205 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USING HER INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425088 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR