BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERAQUEST RUBELLA IGG EIA TEST KIT

    MDR report key: 2629772 · Received June 1, 2012

    Report

    Report Number
    1061839-2012-00001
    Event Type
    Other
    Date Received
    June 1, 2012
    Date of Event
    May 7, 2012
    Report Date
    June 1, 2012
    Manufacturer
    QUEST INTL., INC.
    Product Code
    LFX
    PMA / PMN Number
    K961053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN THE EVENT WAS REPORTED TO QUEST INTERNATIONAL, INC., QUEST INTERNATIONAL, INC. CONSIDERED IT A NON-REPORTABLE EVENT BASED ON IT'S INTERNAL SOP AND FDA CFR PART 803.1. NEVERTHELESS, SINCE THE DISTRIBUTOR, (B)(6), DECIDED TO REPORT THE EVENT, QUEST INTERNATIONAL, INC. IS ALSO REPORTING THE EVENT. ROOT CAUSE: BASED ON ALL THE INFO OBTAINED AND ANALYZED IN THE INVESTIGATION OF THE COMPLAINT, THE ROOT CAUSE OF THE FAILURE CAN NOT BE ATTRIBUTED TO MFG FAILURE, QUALITY CONTROL FAILURE OR REAGENT INTEGRITY FAILURE (REFER TO REPORT ATTACHED). CORRECTIVE ACTION: BASED ON THE DATA AND INFO AVAILABLE, THE COMPANY CONSIDERS THIS AN ISOLATED EVENT AT THIS TIME. NO INTERNAL CORRECTIVE ACTION REQUIRED. CUSTOMER NOTIFIED.

    Description of Event or Problem · 1

    ON (B)(4) 2012, (B)(6) NOTIFIED QUEST INTERNATIONAL, INC. THAT ONE OF (B)(6) CUSTOMERS WAS RUNNING AN ASSAY USING INTERNAL KNOWN POSITIVE SAMPLES ALONG WITH UNK PT SAMPLES USING AUTOMATED MICROPLATE ANALYZER. WHEN REVIEWING THE RESULTS, THE CUSTOMER NOTICED THAT ON THE SECOND STRIP CONTAINING 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. THE CUSTOMER RE-ASSAYED THE 4 PT SAMPLES AND ALL WERE POSITIVE. THE CUSTOMER STATED THAT CORRECTED RESULTS WERE SENT TO THE PHYSICIAN AS THE INITIAL NEGATIVE RESULTS HAD BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1