BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4123549 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29735
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THERE IS A BLACKLIGHT ANOMALY AND THE BUTTONS ARE BEING UNRESPONSIVE. THE LAST BLOOD GLUCOSE READING WAS 245 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600276 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR