BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP CLEAR

    MDR report key: 4133318 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-10759
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 BY THE CUSTOMER'S FATHER THAT THE CUSTOMER HAD A BROKEN BELT CLIP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 454 MG/DL. CUSTOMER DOES NOT REPORT THE BELT CLIP IS COMING OFF THE INSULIN PUMP. CUSTOMER REPORTED THAT THE TOP BROKE OFF THE BELT CLIP AND IT OCCURRED WHEN SHE PULLED IT OFF HER SHIRT. BELT CLIP WILL BE REPLACED AS A COURTESY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611061 BELT CLIP CLEAR OYC MEDTRONIC MINIMED MMT-640CL

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR