BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAL PRDGM INS CL EN RC

    MDR report key: 1844865 · Received September 22, 2010

    Report

    Report Number
    2032227-2010-82719
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    June 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 REPORTED THAT HE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS UNCONSCIOUS WHEN THE PARAMEDICS ARRIVED. THE CUSTOMER FELT THAT THE EVENT WAS CAUSED BY THE INSULIN PUMP NOT BEING PROGRAMMED CORRECTLY. THE CUSTOMER HAS HAD NO ISSUES SINCE THE EVENT, AND FELT NO NEED TO CONDUCT TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization