BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2972060 · Received February 21, 2013

    Report

    Report Number
    2032227-2013-00683
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 17, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 CUSTOMER GOT A MOTOR ERROR ALARM, AND WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE OF 575 MG/DL. TROUBLESHOOTING WAS NOT CONDUCTED AS THE CALLER DID NOT HAVE THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77168 INSULIN INFUSION PUMP L2G LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization