BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1780300 · Received July 26, 2010

    Report

    Report Number
    2032227-2010-82007
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 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 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 FOR HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE ACTIVATE BUTTON IN THE INSULIN PUMP WAS NOT RESPONDING PROPERLY AND AFTER THE BLOOD GLUCOSE IS PROGRAMMED INTO THE DEVICE, THE CUSTOMER WAS NOT ABLE TO PRESS THE ACTIVATE BUTTON TO ENTER THE CARBOHYDRATES. THE SPOUSE STATED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE, WAS SWEATING, AND PASSED OUT. PRIOR TO BEING HOSPITALIZED THE BLOOD GLUCOSE READING WAS 480 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAL PRDGM INS CL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization