BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCCULT

    MDR report key: 14536 · Received July 6, 1994

    Report

    Report Number
    MW1002729
    Event Type
    Malfunction
    Date Received
    July 6, 1994
    Manufacturer
    SMITH KLINE DIAGNOSTICS, INC.
    Product Code
    KHE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CARDS USED TO DETECT FECAL OCCULT BLOOD AND CARDS USED TO DETECT OCCULT BLOOD IN GASTRIC SPECIMENS ARE REQUIRED BY MFR TO BE STORED IN THE DARK. "PROTECT FROM LIGHT" STATED ON THE PACKAGE. THE PRODUCT IS USED THROUGHOUT MANY HOSP AREAS, DR'S OFFICES, AND CLINICS. INVARIABLY THE BOX IS OPENED AND LEFT IN THE EXAM ROOMS, STOCKED UTILITY CARTS, ETC AND EXPOSED TO LIGHT. RPTR FEELS MFR SHOULD TAKE RESPONSIBILITY FOR THIS PROBLEM IN ITS PACKAGING AND NOT LEAVE IT TO USERS. POTENTIAL FOR CITATION BY REGULATORY AGENCIES HCFA, JCAHO, CAP, ETC FOR IMPROPER STORAGE. POTENTIAL FOR TEST PAPER INSIDE CARD TO DISCOLOR AND MAKE READING TEST DIFFICULT. PERHAPS SHOULD BE FOIL WRAPPED INDIVIDUAL PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCCULT TEST CARD FOR FECAL OCCULT BLOOD KHE SMITH KLINE DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *