BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1931206 · Received December 10, 2010

    Report

    Report Number
    2032227-2010-83401
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER STATED THAT HE EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVELS OVER THE WEEKEND, AND ENDED UP IN THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVELS ABOVE 600 MG/DL. THE CUSTOMER THEN EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND LOST CONSCIOUSNESS. THE CUSTOMER STATED THAT HE HAD TREATED HIS BLOOD GLUCOSE LEVELS WITH A MANUAL INJECTION AND A BOLUS. THE CUSTOMER UNDERSTANDS THAT HE OVER TREATED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization