BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3841640 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02168
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 THAT THE PUMP GAVE A MOTOR ERROR ALARM DURING THE BASAL RATE DELIVERY. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE DRIVE SUPPORT CAP WAS FLUSH. THE PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE PUMP DID PASS THE PRIME, DISPLACEMENT AND SELF TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318203 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1