BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3192633 · Received June 27, 2013

    Report

    Report Number
    2032227-2013-02595
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST DUE TO A LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP PASSED THE DISPLACEMENT AND REWIND TESTS. NO REWIND ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP IS STUCK IN THE REWIND MODE. IT WAS REPORTED THAT THE ALARM HISTORY CANNOT BE ACCESSED DUE TO THE REWIND ANOMALY. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294074 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR