BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1870143 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82920
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 25, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS WITH A READING OF 23 MG/DL. PRIOR TO THE EVENT, CUSTOMER WAS WORKING OUTSIDE WHEN HE TREATED FOR A BLOOD GLUCOSE READING BY DELIVERING A BOLUS AND AN INJECTION. TROUBLESHOOTING WAS NOT PERFORMED BECAUSE CUSTOMER WAS ASLEEP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization