BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP

    MDR report key: 4120959 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29419
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    April 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    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 THE CUSTOMER HAD A BROKEN HOLSTER. THE CUSTOMER'S BLOOD GLUCOSE WAS 406 MG/DL. THE CUSTOMER WAS TREATED WITH AN INJECTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601565 BELT CLIP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-612

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR