BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINGER SENSOR USED BY ONEBLOOD DONATION CENTER

    MDR report key: 14856268 · Received June 28, 2022

    Report

    Report Number
    MW5110608
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 26, 2022
    Manufacturer
    UNK
    Product Code
    QGU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I ATTEMPTED TO DONATE BLOOD FOR ONEBLOOD. I WAS DENIED BECAUSE THE SENSOR DETECTED THAT I WAS LOW ON IRON. THIS HAPPENED EVEN THOUGH I HAD AN ACTUAL BLOOD DRAW, AND IRON WAS TESTED BY QUEST LABORATORY ON (B)(6) 2022 AND THE LEVELS WERE WELL WITHIN ACCEPTABLE RANGE. THEREFORE, THE SENSORS THEY ARE USING ARE INVALID. ACTUAL BLOOD TEST WAS DONE ON THE ABOVE DATE (B)(6) 2022 BY QUEST DIAGNOSTICS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421738 FINGER SENSOR USED BY ONEBLOOD DONATION CENTER HEMOGLOBIN FOR DONOR TESTING QGU UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Other