BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP

    MDR report key: 4170126 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37754
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS DUE TO NOT KNOWING THAT INSULIN WAS BEING INJECTED. CUSTOMER STATED THAT THEY PASSED OUT AND BROKE THE BELT CLIP. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL 136MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649548 BELT CLIP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-642

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR