BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2193388 · Received July 29, 2011

    Report

    Report Number
    2032227-2011-01879
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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

    DURING A PHONE CALL WITH THE SALES DEPT, THE CUSTOMER BEGAN TO SHOW SIGNS OF HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE WAS 260 MG/DL, WHICH SHE TREATED WITH 2.0 UNITS OF INSULIN. THE CUSTOMER WAS ALSO VOMITING, NAUSEOUS AND WEAK. THE PARAMEDICS WERE CALLED TO THE CUSTOMER'S HOME FOR ASSISTANCE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL NOT SPECIFIED INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention