BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3143572 · Received June 3, 2013

    Report

    Report Number
    2032227-2013-02219
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE BOLUS AND OCCLUSION TESTS. THE INSULIN PUMP WAS MONITORED AND NO BOLUS DELIVERY BY ITS OWN NOTED. THE INSULIN PUMP HAD MISSING SEGMENTS DUE TO OPEN HEAT BOND OF CONNECTOR SHORT SIDE ON LCD.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS OVER DELIVERING INSULIN ON ITS OWN, AND HER BLOOD GLUCOSE WAS GOING LOW. TROUBLESHOOTING WAS PERFORMED, AND THE LEAD SCREW DID OVER ROTATE. THE CALLER MENTIONED THAT THE DEVICE ALSO HAD MISSING SEGMENTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244217 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR