BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4243291 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-40485
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP ALARMED MOTOR ERROR AFTER A NO DELIVERY. MOTOR ERROR OCCURRED FOR THE FIRST TIME. CUSTOMER'S MOTHER WAS ADVISED TO CHANGE THE INFUSION SET. CUSTOMER'S MOTHER PERFORMED A SELF TEST AND THE DEVICE PASSED. POSSIBLE OCCLUSION ON THE RESERVOIR AND OR INFUSION SET. CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725904 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWB

    Patients

    Seq Age Sex Outcome Treatment
    1