BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELT CLIP

    MDR report key: 3945847 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04732
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Product Problem
    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 EXPERIENCED HIGH BLOOD GLUCOSE OF 400 MG/DL. SHE STATED SHE WAS HAVING PROBLEMS WITH THE INSULIN INFUSION SET CANNULA STAYING IN HER BODY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425832 BELT CLIP CGM MDS MEDTRONIC MINIMED MMT-612

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR UNOMEDICAL INFUSION SET