BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® C. DIFFICILE GDH

    MDR report key: 7674193 · Received July 10, 2018

    Report

    Report Number
    3002769706-2018-00104
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Report Date
    January 8, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    MCB
    PMA / PMN Number
    K132010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED IN RESPONSE TO A CUSTOMER REPORT FROM FRANCE THAT THE VIDAS® GDH ASSAY PROVIDED A FALSE POSITIVE RESULT FOR A PATIENT STOOL SPECIMEN. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. EVALUATION OF THE MANUFACTURING BATCH RECORDS INDICATED THERE WAS NO ANOMALY OR NONCONFORMANCE DURING THE MANUFACTURING, CONTROL OR PACKAGING PROCESSES. INVESTIGATIONAL TESTING OF FOUR (4) INTERNAL SAMPLES AGAINST SEVEN (7) VIDAS GDH BATCHES (INCLUDING THE CUSTOMER'S BATCH NUMBER) OBTAINED RESULTS WITHIN THE DOCUMENTED PERFORMANCE SPECIFICATIONS AND SHOWING NO DRIFT AS COMPARED TO PREVIOUS TESTING. TESTING WAS PERFORMED ON TWO (2) DIFFERENT VIDAS 3 INSTRUMENTS. THE INVESTIGATION DID NOT REPRODUCE THE CUSTOMER'S RESULT OF FALSE POSITIVE. THE VIDAS GDH ASSAY PERFORMED AS INTENDED. THE PRODUCT INSTRUCTIONS FOR USE (IFU), "SPECIMENS" SECTION STATE: "IT IS CRITICAL THAT STOOL SPECIMENS BE THOROUGHLY MIXED BEFORE SAMPLE PROCESSING IS BEGUN. LACK OF HOMOGENEITY IN A STOOL SAMPLE MAY LEAD TO INCORRECT RESULTS. THOROUGH MIXING OF STOOL SPECIMENS IS ESSENTIAL TO AVOID THIS PROBLEM. THE DILUTED SAMPLE MUST BE HOMOGENEOUS AFTER MIXING. THIS WILL HELP ENSURE VALID RESULTS. FOR THIS SAMPLE PREPARATION STEP, IT IS ESSENTIAL TO CHECK THE AMOUNT OF DEPOSITED SAMPLE REGARDLESS OF THE CONSISTENCY OF THE STOOLS (LIQUID, SEMI-SOLID OR SOLID). IF THE CUSTOMER COMPLAINT ANOTHER TIME, PROPOSE HIM TO SEND A FAS TO REMIND THE DIFFERENT PROTOCOLE SPECIFIQUE FOR EACH KIND OF STOOL."

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY OBTAINED A FALSE POSITIVE RESULT WHEN USING THE PRODUCT VIDAS® GDH (REF. 30125), LOT 1006161620. THE CUSTOMER PERFORMED A CORRELATION STUDY BETWEEN TWO VIDAS 3 ANALYZERS (VIDAS (B)(4) AND VIDAS (B)(4)) FOR VIDAS GDH. THE RESULTS WERE OBTAINED AS FOLLOWS: SAMPLE 1: STOOL VOLUME NOT DOUBLED: 1ST TEST ON VIDAS (B)(4) WAS OBTAINED POSITIVE AT 0.25, 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 (B)(4) WAS OBTAINED NEGATIVE AT 0.00 (NON-STANDARD C1 CONTROL), 2ND TEST ON VIDAS (B)(4) WAS OBTAINED NEGATIVE AT 0.00 (NON-STANDARD C1 CONTROL). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516996 VIDAS® C. DIFFICILE GDH VIDAS® GDH MCB BIOMERIEUX SA 1006161620

    Patients

    Seq Age Sex Outcome Treatment
    1