BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4111431 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27600
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 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

    (B)(4). INSULIN PUMP HAD NO BUTTON ERROR ALARM. DEVICE HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACE. DEVICE RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER REMOVED THE BATTERY AND 3 OR 4 HOURS LATER REINSERTED IT AND PROBLEM PERSISTED. IT WAS ALSO STATED THAT THE BUTTONS DID NOT RESPOND PROPERLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590001 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715WWP

    Patients

    Seq Age Sex Outcome Treatment
    1