BEUDAMED
    FDA Adverse Event Summary report: N

    EBV VCA IGG

    MDR report key: 3812317 · Received May 7, 2014

    Report

    Report Number
    3022521-2014-00004
    Date Received
    May 7, 2014
    Date of Event
    February 23, 2014
    Report Date
    May 1, 2014
    Manufacturer
    QUEST INTERNATIONAL, INC.
    Product Code
    LSE
    PMA / PMN Number
    K990410
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER CONTACTED BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT CONCERNING A RESULT OBTAINED WHEN RUNNING THE BIO-RAD EBV VCA IGG ASSAY WITH A MICROPLATE READER. THE USER-DEFINED PROGRAM FOR THIS ASSAY ON THE MICROPLATE READER WAS INCORRECTLY PROGRAMMED BY THE CUSTOMER TO NOT INCLUDE THE EQUIVOCAL RANGE RESULT INTERPRETATION FOR 0.9-1.1 INDEX AS MENTIONED IN THE PACKAGE INSERT. DUE TO THIS ERROR, A PATIENT TEST RESULT OF 0.948 INDEX WHICH SHOULD HAVE RESULTED IN "EQUIVOCAL" RESULT INTERPRETATION RESULTED IN "NEGATIVE" RESULT INTERPRETATION. THE CUSTOMER CAUGHT THE ERROR AND CORRECTLY REPORTED THIS PATIENT RESULT AS EQUIVOCAL. ON (B)(6) 2014, THE CUSTOMER REPORTED 12 SAMPLES THAT WERE INCORRECTLY REPORTED AS NEGATIVE INSTEAD OF EQUIVOCAL UPON PERFORMING A LOOK BACK OF PREVIOUS RUNS OF THIS ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276659 EBV VCA IGG IVD, EIA LSE QUEST INTERNATIONAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1