BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 3942799 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04463
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 A CUSTOMER'S BLOOD GLUCOSE WENT VERY HIGH TWICE IN ONE WEEK, WITH NO SPECIFIC BLOOD GLUCOSE CONCENTRATION CITED. IT WAS STATED THAT ONE OF THE TWO TIMES, A NO DELIVERY ALARM OCCURRED. THIS REPORT WAS RETRIEVED ON AN ONLINE DIABETES COMMUNITY VIA SOCIAL MEDIA. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419140 MODEL NOT SPECIFIED OYZ FPA MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1