BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® GDH

    MDR report key: 7544663 · Received May 25, 2018

    Report

    Report Number
    3002769706-2018-00070
    Event Type
    Malfunction
    Date Received
    May 25, 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

    A CUSTOMER IN FRANCE HAD NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE RESULT ASSOCIATED WITH VIDAS® GDH (REFERENCE 30125). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. BATCH RECORD REVIEW: THERE IS NO CAPA NOR NON-CONFORMITY 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 AND CONTROL PROCESSES. STUDY OF INTERNAL SAMPLES CONTROL CHARTS: ANALYSIS WAS MADE ON FOUR (4) INTERNAL SAMPLES WITH DIFFERENT CONCENTRATIONS AND ON SEVEN (7) BATCHES INCLUDING THE BATCH MENTIONED BY THE CUSTOMER. VIDAS GDH BATCH 1006161620/190127-0 IS IN THE TREND ANALYSIS COMPARED TO THE OTHER BATCHES. TESTING BY BIOMÉRIEUX: FOUR (4) INTERNAL SAMPLES WERE TESTED (TWO STOOLS TO PREPARE GDH002 & GDH005 AND TWO SUPERNATANTS READY TO USE GDH027 & GDH031) AND CALIBRATION ON TWO (2) VIDAS 3 INSTRUMENTS. (B)(4). ALL OF THE RESULTS WERE WITHIN THEIR SPECIFICATION AND THE SAME BETWEEN THE TWO (2) INSTRUMENTS. THE VIDAS GDH 1006161620/190127-0 IS WITHIN THE EXPECTED PERFORMANCE. THE CUSTOMER'S ISSUE WAS NOT REPRODUCED. CONCLUSION: ACCORDING TO THE DATA MENTIONED ABOVE, VIDAS GDH, BATCH 1006161620/190127-0, PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE RESULT ASSOCIATED WITH VIDAS® GDH (REFERENCE (B)(4)). THE CUSTOMER REPORTED WHILE PERFORMING A CORRELATION STUDY BETWEEN TWO (2) VIDAS®3 ANALYZERS FOR VIDAS® GDH THE DISCREPANCY WAS OBSERVED. THE RESULTS WERE AS FOLLOWS: SAMPLE 1: STOOL VOLUME WAS NOT DOUBLED; THE LIQUID STOOL SAMPLE HAD CLEAR SEPARATION AND PERFECT SUPERNATANT. 1ST TEST ON VIDAS® (B)(4) WAS OBTAINED POSITIVE AT 0.15. 2ND TEST ON VIDAS® (B)(4) WAS OBTAINED NEGATIVE AT 0.00. SAMPLE 2: DOUBLED STOOL VOLUME AND VOLUME OF R1. 1ST TEST ON VIDAS® 3 (B)(4) WAS OBTAINED NEGATIVE AT 0.00. 2ND TEST ON VIDAS® 3 (B)(4) WAS OBTAINED NEGATIVE AT 0.05. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387679 VIDAS® GDH VIDAS® GDH MCB BIOMERIEUX SA 1006161620

    Patients

    Seq Age Sex Outcome Treatment
    1