BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3800803 · Received May 8, 2014

    Report

    Report Number
    2032227-2014-02132
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. NO ALARM NOTED. THE DEVICE HAD A SCRATCHED LCD WINDOW, AND CRACKS ON THE LCD WINDOW CORNERS, RESERVOIR TUBE LIP, BATTERY TUBE THREADS, AND THE CASE, NEAR THE DISPLAY WINDOW CORNERS. THE UNIT ALSO HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP GAVE THE PATIENT AN ALARM DURING THE REWIND PROCESS, DUE TO A BROKEN FORCE SENSOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279318 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1