BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP PUMP CLEAR

    MDR report key: 4090534 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23164
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 475 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE, ADVISING THAT SHE WOULD TREAT FOR IT LATER. SHE STATED THAT SHE HAD BROKEN HER INSULIN PUMP'S BELT CLIP AND REQUESTED A REPLACEMENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570249 BELT CLIP PUMP CLEAR CGM MDS MEDTRONIC MINIMED MMT-631CL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR