BEUDAMED
    FDA Adverse Event Summary report: N

    RHEUMATEX

    MDR report key: 15451 · Received August 23, 1994

    Report

    Report Number
    MW1003153
    Date Received
    August 23, 1994
    Date of Event
    June 1, 1994
    Report Date
    August 18, 1994
    Manufacturer
    WAMPOLE LABORATORIES
    Product Code
    DHR
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PROFICIENCY TESTING FAILED 2 OF 5 BOTH POSITIVE, RPTR'S RESULT NEGATIVE. RETESTED PROFICIENCY SAMPLES 8/94, WITH ANOTHER KIT. ONE SAMPLE STILL NEGATIVE, OTHER SAMPLE VERY WEAK POSITIVE. TESTED ON KIT WITH BETTER EXPIRATION DATE, IE 10/31/94. NOW BOTH SAMPLES GIVE POSITIVE RESULTS. IT WOULD APPEAR THAT BOTH KITS USED WITH 8/31/94, EXPIRATION DATE HAVE LOST POTENCY AND SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATEX DHR WAMPOLE LABORATORIES 351304, 351306

    Patients

    Seq Age Sex Outcome Treatment
    1 *