BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2021290 · Received March 7, 2011

    Report

    Report Number
    2032227-2011-00554
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO A CORRODED ELECTRONIC ASSEMBLY. MOISTURE DAMAGE WAS ALSO FOUND ON THE MOTOR HOME SWITCH. UNABLE TO VERIFY THE BUTTON ERROR ALARM, BUTTON/KEYPAD ANOMALY OR PERFORM FUNCTIONAL TESTING DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 56 MG/DL. THE CUSTOMER ALSO REPORTED A BUTTON ERROR ALARM. THE CUSTOMER COULDN'T RECALL PRESSING BUTTONS, AND WAS UNABLE TO CLEAR THE ALARM. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization