BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-HEMOGLOBIN PHOTOMETER

    MDR report key: 36718 · Received September 5, 1996

    Report

    Report Number
    MW1009861
    Event Type
    Malfunction
    Date Received
    September 5, 1996
    Report Date
    August 29, 1996
    Manufacturer
    HEMOCUE, INC.
    Product Code
    KHG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RESULTS OF A CAPILLARY SPECIMEN TESTED ON DEVICE ARE UNACCEPTABLY HIGH WHEN COMPARED WITH A SIMULTANEOUS VENOUS SPECIMEN. THIS HAS THE POTENTIAL FOR ALLOWING RPTR TO ACCEPT DONORS WHO WOULD OTHERWISE BE DEFERRED ON THE BASIS OF A LOW HEMOGLOBIN. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B-HEMOGLOBIN PHOTOMETER HEMOGLOBIN PHOTOMETER KHG HEMOCUE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO