BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508LUC EA INSULIN CH EN US LN

    MDR report key: 1911770 · Received November 24, 2010

    Report

    Report Number
    2032227-2010-83286
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 WAS ADMITTED IN THE EMERGENCY ROOM FOR LOW BLOOD GLUCOSE. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS LOW TWO DAYS AGO, AND SHE FELL AND BROKE HER HIP. IT WAS STATED THAT THE CUSTOMER WOULD GO FOR HIP SURGERY. IT WAS ALSO STATED THAT THE INSULIN PUMP WAS 11 HOURS OFF. TROUBLESHOOTING WAS PERFORMED. THE BOLUS HISTORY REVEALED A BOLUS, WHICH MAY HAVE CAUSED HER LOW BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508LUC EA INSULIN CH EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508LUC

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization