BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP

    MDR report key: 3961091 · Received July 28, 2014

    Report

    Report Number
    2032227-2014-04833
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    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. SEE MEDWATCH REPORT 2032227-2014-04840.

    Description of Event or Problem · 1

    WHILE INQUIRING ABOUT THE SHIPMENT OF THEIR PRODUCT, THE CUSTOMER REPORTED A PAST EVENT OF EMERGENCY ROOM VISIT DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT THEY WERE TRAVELING AND FORGOT TO TAKE THEIR INSULIN WITH THEM. THEY WERE UNABLE TO TREAT THE HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 150 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439618 BELT CLIP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-640CL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization