BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1812322 · Received August 20, 2010

    Report

    Report Number
    2032227-2010-82390
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 TO REPORT HIGH BLOOD GLUCOSE LEVELS OF 600 MG/DL, AND WANTED TO MAKE SURE THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER WAS TIRED, VOMITING AND THIRSTY. THE CUSTOMER HAD ALREADY GIVEN HERSELF A MANUAL INJECTION, BUT HER BLOOD GLUCOSE LEVELS REMAINED ELEVATED. THE CUSTOMER CALLED HER DOCTOR FOR ASSISTANCE, AND SHE WAS TOLD TO GO TO THE HOSPITAL. 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 43 YR Hospitalization