BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2031088 · Received March 16, 2011

    Report

    Report Number
    2032227-2011-00662
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES. THE INSULIN PUMP HAD A SLIGHT RATTLE DUE TO NORMAL MOTOR SLEEVE FITMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 295 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER WAS CAUGHT IN A THUNDERSTORM. THE INSULIN PUMP GOT WET, AND THE BUTTONS STOPPED RESPONDING. THE CUSTOMER ALSO STATED THAT HE CAN HEAR WATER INSIDE THE INSULIN PUMP. 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 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization