BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB-BASED DATA MANAGEMENT

    MDR report key: 2002463 · Received February 16, 2011

    Report

    Report Number
    2032227-2011-00450
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P989922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    THE CUSTOMER CALLED WITH A BLOOD GLUCOSE READING OF 438 MG/DL. THE CUSTOMER HAD ALREADY TREATED WITH A BOLUS. THE CUSTOMER THEN MENTIONED THAT HE HAD BEEN HOSPITALIZED FOR BLOOD GLUCOSE LEVELS OVER 1000 MG/DL SEVERAL MONTHS AGO. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEB-BASED DATA MANAGEMENT CGMS SOFTWARE (MDS) MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization