BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELT CLIP

    MDR report key: 3930822 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03594
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    CUSTOMER'S MOTHER STATED THAT SON'S BELT CLIP BROKE. THE BLOOD GLUCOSE READING IS 498 MG/DL. THE PLASTIC ON THE PIN BROKE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408583 BELT CLIP CGM MDS MEDTRONIC MINIMED MMT-640CL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR