BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMAPROMPT FG

    MDR report key: 9817722 · Received March 11, 2020

    Report

    Report Number
    9817722
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 25, 2020
    Report Date
    February 27, 2020
    Manufacturer
    AERSCHER DIAGNOSTICS
    Product Code
    KHE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HEMAPROMPT TESTING AREA NOTED TO ALREADY BE TINTED BLUE PRIOR TO SPECIMEN ON AREA. LOT #159, 161. THE REMAINDER FOR LOT #159, 161 REMOVED FROM STOCK. TESTING PERFORMED ON DIFFERENT LOT OF HEMAPROMPT TESTING STRIPS.

    Description of Event or Problem · 1

    HEMAPROMPT TESTING AREA NOTED TO ALREADY BE TINTED BLUE PRIOR TO SPECIMEN ON AREA. LOT #159, 161. THE REMAINDER FOR LOT #159, 161 REMOVED FROM STOCK. TESTING PERFORMED ON DIFFERENT LOT OF HEMAPROMPT TESTING STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282770 HEMAPROMPT FG REAGENT, OCCULT BLOOD KHE AERSCHER DIAGNOSTICS HPFG 159 / 161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown