BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMB HGB MONITOR

    MDR report key: 21104936 · Received January 7, 2025

    Report

    Report Number
    MW5164404
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    January 4, 2025
    Report Date
    January 4, 2025
    Manufacturer
    ORSENSE LTD.
    Product Code
    QGU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE BLOOD CENTER'S USE OF AN ORSENSE THUMB HGB MONITOR GAVE FALSE READINGS AND PREVENTED PATIENT FROM DONATING BADLY NEEDED BLOOD. SPECIFICALLY, (B)(6) 2024, ORSENSE 11.6 G/DL HGB, AND (B)(6) 2025 12.4 G/DL. IN CONTRAST, A LAB BLOOD DRAW/CBC(COMPLETE BLOOD COUNT) ON (B)(6) 2024 GAVE A HGB LEVEL OF 14.0 G/DL. THIS INACCURACY COULD AFFECT MANY OTHER PATIENTS AND REDUCE AVAILABILITY OF BLOOD DONATIONS. PATIENT HAS NO HISTORY OF ANEMIA AND NO SYMPTOMS OF ANEMIA. REF REPORT: MW5164405.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323484 THUMB HGB MONITOR HEMOGLOBIN FOR DONOR TESTING QGU ORSENSE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other