BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4240708 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49692
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST AND THE EXCESSIVE NO DELIVERY TEST. NO UNEXPECTED NO DELIVERY ALARM NOTED. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, SCRATCHED RESERVOIR TUBE WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS RECEIVING EXCESSIVE NO DELIVERY ALARMS. CUSTOMER'S BLOOD GLUCOSE WAS 150 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724174 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712WWS

    Patients

    Seq Age Sex Outcome Treatment
    1