BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP

    MDR report key: 4103472 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26375
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    CUSTOMER REPORTED THAT SHE WAS LAYING ON THE COUCH, HAD A VERY LOW BLOOD GLUCOSE LEVEL AND FELL OFF THE COUCH; THE BELT CLIP BROKE OFF THE INSULIN PUMP. CUSTOMER STATED HER HUSBAND FOUND HER AND THEY WERE ABLE TO TREAT. CUSTOMER STATED HER BLOOD GLUCOSE WAS LOW, BUT DID NOT KNOW HOW LOW. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583686 BELT CLIP OYC MEDTRONIC MINIMED MMT-642

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention