BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERAQUEST RUBELL IGG EIA TEST KIT

    MDR report key: 2588332 · Received May 23, 2012

    Report

    Report Number
    3022521-2012-00001
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Date of Event
    April 21, 2012
    Report Date
    May 23, 2012
    Manufacturer
    QUEST INTERNATIONAL, INC.
    Product Code
    LFX
    PMA / PMN Number
    K961053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, A CUSTOMER CONTACTED THE BIO-RAD LAB TECHNICAL SUPPORT DEPT CONCERNING RESULTS OBTAINED WHEN RUNNING THE RUBELLA IGG EIA TEST KIT. THIS CUSTOMER WAS RUNNING AN ASSAY USING INTERNAL KNOWN POSITIVE SAMPLES ALONG WITH UNK PT SAMPLES USING AUTOMATED MICROPLATE EQUIPMENT. WHEN REVIEWING THE RESULTS, THE CUSTOMER NOTICED THAT ON THE SECOND STRIP CONTAINING FOUR (4) KNOWN POSITIVE SAMPLES AND (4) UNK PT SAMPLES, ALL RESULTS WERE NEGATIVE WITH VERY LOW ODS. THE FOUR KNOWN SAMPLES HAD PREVIOUSLY TESTED AS HIGH POSITIVE (22-36 IU/ML). THE CUSTOMER RE-ASSAYED THE FOUR (4) PATIENT SAMPLES AND ALL WERE POSITIVE. THE CUSTOMER STATED THAT CORRECTED RESULTS WERE SENT TO THE PHYSICIANS AS THE INITIAL NEGATIVE RESULTS HAD BEEN REPORTED. THE BIO-RAD LAB PRODUCT SUPPORT DEPT FORWARDED THE CUSTOMER¿S INFO TO THE MFR, QUEST INTERNATIONAL, INC. FOR INVESTIGATION. PER THE MFR¿S INVESTIGATION, THIS FAILURE IS NOT ATTRIBUTED TO A MFG OR QUALITY CONTROL FAILURE, OR A FAILURE OF REAGENT INTEGRITY. BASED ON THE DATA AND INFO AVAILABLE, THE MFR CONSIDERS THIS AN ISOLATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERAQUEST RUBELL IGG EIA TEST KIT IVD, EIA LFX QUEST INTERNATIONAL, INC. M0801

    Patients

    Seq Age Sex Outcome Treatment
    1