BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 11435369 · Received March 5, 2021

    Report

    Report Number
    MW5099836
    Event Type
    Malfunction
    Date Received
    March 5, 2021
    Date of Event
    October 15, 2020
    Report Date
    March 4, 2021
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE FUNCTION WAS NOT WORKING I DIDN'T HAVE EXACT DATE, BUT I HAD TO STOP USING THE FEATURE. THE SENSOR IS SO INACCURATE TOO I DON'T KNOW WHAT I AM GOING TO DO. (SAYS MY AVERAGE IS A1C - 7.2 RANGE ACTUAL RESULTS ARE MID 8'S WASN'T THIS FAR OFF IN THE PAST HAD SENSOR RESULTS 7.2 (ACTUAL WAS 7.5 - 7.7) GETTING SO FAR OFF MY DOCTOR SAYS TO ME "YOU HAVE THE WORST PRODUCT ON THE MARKET" - "USED TO BE BEST". MY A1C FOR THE QUARTER (B)(6) 2020 WAS SO FAR OFF MY NEXT A1C WILL BE IN (B)(6) 2021 (I DON'T HAVE EXACT DATES MY DOCTOR HAS THE REPORTS) HE USED TO LIKE MEDTRONIC BUT FEELS THE DEVICES ARE SO OFF NOW THAT THEY ARE NOT RELIABLE ANYMORE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323246 MEDTRONIC MINIMED AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED "570G (TRIED TO MAGNIFY)"

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other