BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP

    MDR report key: 4210573 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43501
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 BROKE HER BELT CLIP. HER BLOOD GLUCOSE WAS UNK AT THE TIME OF REPORTING, BUT HAD BEEN 400 MG/DL AT LAST READING. NO EQUIPMENT IS BEING RETURNED. NO ADDITIONAL INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680521 BELT CLIP OYC MEDTRONIC MINIMED MMT-631CL

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other