BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM V2.2 CL EN

    MDR report key: 1063286 · Received June 19, 2008

    Report

    Report Number
    3004209178-2008-00425
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 56 MG/DL. IT WAS REPORTED THAT THE CUSTOMER HAD TRIPPED OVER HER BIKE. THE SENSOR READING SHOWED 130 MG/DL AND THE DOWN ARROW WAS UNRESPONSIVE UPON ARRIVAL AT THE HOSPITAL. THE CUSTOMER CALLED BACK AFTER REVIEWING THE CARELINK DATA. INFORMED CUSTOMER OF POSSIBLE CALIBRATION TIMING ISSUE. THE CUSTOMER STATED THAT SHE TOOK A BOLUS AND DID FIRST THE CALIBRATION FIFTEEN MINUTES LATER. ALSO IT APPEARS THAT THE CUSTOMER MAY HAVE OVERBOLUSED BETWEEN MEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM V2.2 CL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization