BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAB PRDGM INS BL EN RC

    MDR report key: 1812006 · Received August 17, 2010

    Report

    Report Number
    2032227-2010-82375
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 24, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS OF 469 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER WAS NOT FEELING WELL AND WAS VOMITING. THE CUSTOMER HAD TOLD HIS FATHER THAT FOR THE PAST TWO DAYS, THE INSULIN PUMP HAD NO INSULIN IN THE RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAB PRDGM INS BL EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization