BEUDAMED
    FDA Adverse Event Summary report: N

    COLOR SLIDE II

    MDR report key: 14727 · Received July 15, 1994

    Report

    Report Number
    MW1002848
    Date Received
    July 15, 1994
    Date of Event
    April 1, 1994
    Report Date
    July 1, 1994
    Manufacturer
    SERADYN, INC.
    Product Code
    LJN
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IN 4/94, WE BEGAN NOTICING AN INCREASE IN POSITIVE MONOSPOT TESTS USING DEVICE. AT THAT TIME, THE CO WAS NOTIFIED AND SEVERAL SAMPLES AND THE KIT IN USE WERE SENT TO THEM. THEIR TECHNICAL SVC REP AGREED THAT THESE RESULTS WERE FALSE POSITIVES. SINCE THEN WE HAVE BEEN CHECKING ALL POSITIVES BY ANOTHER METHOD AND HAVE FOUND SEVERAL MORE FALSE POSITIVES. CO HAS NOT GIVEN RPTR A RESONABLE EXPLANATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLOR SLIDE II COLOR SLIDE LJN SERADYN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *