BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMAPROMPT FG

    MDR report key: 25183494 · Received May 15, 2026

    Report

    Report Number
    25183494
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    February 23, 2026
    Report Date
    May 5, 2026
    Manufacturer
    AERSCHER DIAGNOSTICS
    Product Code
    KHE
    UDI-DI
    00693501000152
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALL BOXES OF HEMAPROMPT FG GUAIAC CARDS IN ED WITH LOT NUMBER 307 (WHICH IS OUR CURRENT ONLY SUPPLY) HAVE HAD NUMEROUS FAULTY TESTING CARDS. CONTROL AREA IS NOT DEVELOPING THEREFORE RENDERING THE TEST FAULTY AND UNUSABLE. HAS BEEN REQUIRING UTILIZATION OF MULTIPLE CARDS PER PATIENT SPECIMEN TO FIND ONE IN BATCH THAT DOES PASS CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353666 HEMAPROMPT FG REAGENT, OCCULT BLOOD KHE AERSCHER DIAGNOSTICS HPFG 307 00693501000152

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other