BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® C. DIFFICILE GDH

    MDR report key: 7477463 · Received May 1, 2018

    Report

    Report Number
    3002769706-2018-00062
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Report Date
    July 11, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    MCB
    PMA / PMN Number
    K132010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED AFTER A CUSTOMER REPORTED CALIBRATION PROBLEMS WITH VIDAS® GDH (REF 30125). THE CUSTOMER NOTIFIED BIOMÉRIEUX OF A POSITIVE CONTROL C1 OUT OF RANGE ON VIDAS GDH LOT 1006161620/190127-0. THE CUSTOMER OBTAINED: 06APR2018: TV 0.45/0.43 (RANGES : 0.17-0.33 WITH THE FIRST C1 VIAL. 09APR2018: TV 0.27 WITH A SECOND C1 VIAL FROM SAME KIT. RESULT WAS IN CONFORMANCE. BATCH RECORD REVIEW: THERE IS NO CAPA NOR NONCONFORMITY RECORDED ON VIDAS GDH 1006161620/190127-0 LINKED TO THE CUSTOMER'S ISSUE. THE ANALYSIS OF THE BATCH HISTORY RECORDS OF VIDAS GDH 1006161620/190127-0 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL, AND PACKAGING PROCESSES. BIOMERIEUX TESTING RESULTS: THE CALIBRATION TESTED ON THE RETAINED KIT WAS IN CONFORMANCE AND SIMILAR WITH THE IDENTITY KIT (IN NORMAL CONDITION OF RECONSTITUTION, AS INDICATED IN THE PACKAGE INSERT). FOR ADDITIONAL TESTING, 1ML OF DISTILLED WATER WAS PUT IN THE C1 VIAL INSTEAD 2 ML, BEFORE TREATED BY THE R1 VIAL. THE RESULT OBTAINED WAS NOT IN CONFORMANCE WITH A TV=0.46. THEREFORE, THE CUSTOMER'S ANOMALY WAS REPRODUCED DURING THE INTERNAL INVESTIGATION IF THE C1 VIAL WAS RECONSTITUTED WITH 1 ML OF DISTILLED WATER INSTEAD 2 ML. AS A RESULT, THE TEST VALUE (TV) WAS INCREASED. BIOMÉRIEUX IDENTIFIED THE ROOT CAUSE AS A PROBABLE ERROR IN RECONSTITUTION OF THE C1 VIAL BY THE TECHNICIAN, C1 VIAL RECONSTITUTED WITH 1 ML INSTEAD 2 ML OF DISTILLED WATER. IN CONCLUSION, VIDAS GDH LOT 1006161620 IS IN THE EXPECTED SPECIFICATION.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF CALIBRATION PROBLEMS WITH VIDAS® GDH (REF 30125). THE CUSTOMER WAS PERFORMING CALIBRATION TESTING WITH A NEW LOT (1006161620 / 190127-0) ON (B)(6) 2018 AND OBTAINED INVALID CALIBRATION RESULTS. THE CUSTOMER NOTIFIED BIOMÉRIEUX ON (B)(4) 2018 OF THE ISSUE, AND BY THE END OF THE DAY, THE CALIBRATION WAS VALID. THERE WERE PATIENT SAMPLES WAITING MORE THAN 24 HOURS TO BE TESTED. THERE IS NO INDICATION FROM THE LABORATORY THAT THERE WAS ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH DUE TO THIS ISSUE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319697 VIDAS® C. DIFFICILE GDH VIDAS® GDH MCB BIOMERIEUX SA 1006161620

    Patients

    Seq Age Sex Outcome Treatment
    1