BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP

    MDR report key: 4103459 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26356
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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

    THE CUSTOMER HAD CALLED TO REPORT A BROKEN BELT CLIP. THEIR BLOOD GLUCOSE WAS 48 MG/DL, WHICH WAS TREATED WITH GLUCOSE TABLETS. THE CUSTOMER STATED THAT THEY HAD TAKEN TOO MUCH INSULIN, THE NIGHT PRIOR TO THE PHONE CALL, AND THEY HAD TAKEN THE SENSOR OFF BECAUSE IT HAD TIMED OUT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585250 BELT CLIP CGM MDS MEDTRONIC MINIMED MMT-631CL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention