BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEMOCHECK

    MDR report key: 18987021 · Received March 26, 2024

    Report

    Report Number
    MW5153212
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 22, 2024
    Manufacturer
    SANGUINA, INC.
    Product Code
    KHG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I DEPENDED ON FDA APPROVED ANEMOCHECK BY SANGUINA TO MONITOR MY HEMOGLOBIN FROM CHRONIC BLEEDING DUE TO GASTRIC AVMS (ARTERIOVENOUS MALFORMATIONS). EVEN AFTER CALIBRATING WITH THE LAB IT WAS GIVING ME READINGS IN THE RANGE OF 12 TO 14. I FINALLY REALIZED I WAS IN CRISIS WHEN MY HEMOGLOBIN REACHED 6 AND THE MONITOR WAS STILL READING IN THE 13 TO 14 RANGE. I HAD TO HAVE AN EMERGENCY TWO UNITS OF BLOOD. IF I HADN'T DEPENDED ON THIS TECHNOLOGY I WOULD HAVE GONE IN SOONER AND BEEN ABLE TO GET IRON INFUSIONS INSTEAD OF BLOOD. IT REACHED A LOW OF 6.3 BEFORE RECEIVING BLOOD TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725468 ANEMOCHECK WHOLE BLOOD HEMOGLOBIN DETERMINATION KHG SANGUINA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| R| L