BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 1981857 · Received February 2, 2011

    Report

    Report Number
    2032227-2011-00326
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    November 20, 2010
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 HOSPITALIZED DUE TO ERRATIC BLOOD GLUCOSE LEVELS. THE CUSTOMER HAD NOT BEEN USING THE INSULIN PUMP SINCE THE EVENT, AND IT NEEDED TO BE PROGRAMMED. ASSISTED WITH THE PROGRAMMING, BUT THE CALLED DID NOT HAVE SUPPLIES FOR TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization