BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4111436 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27601
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP IS ALARMING BUTTON ERROR. CUSTOMER STATED SHE IS UNSURE IF SHE HELD A BUTTON DOWN FOR 3 MINUTES OR LONGER. CUSTOMER IS UNABLE TO CLEAR THE ALARM. BLOOD GLUCOSE VALUE IS 108 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589674 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS A000114248

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR