BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAB PRDGM INS BL EN RC

    MDR report key: 1780306 · Received July 26, 2010

    Report

    Report Number
    2032227-2010-81991
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 7, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED BECAUSE THE CUSTOMER WAS INVOLVED IN A CAR ACCIDENT AND HIT A TREE. IT WAS STATED THAT WHEN THE PARAMEDICS ARRIVED AT THE SCENE, THE CUSTOMER HAD A LOW BLOOD GLUCOSE. FURTHERMORE, THE DEVICE WAS NOT AVAILABLE FOR TESTING AT TIME OF CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization