BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 7669492 · Received July 9, 2018

    Report

    Report Number
    3002769706-2018-00103
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    November 21, 2017
    Report Date
    August 23, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM FRANCE HAD NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT WITH ONE PATIENT SAMPLE WHEN TESTING WITH VIDAS® CMV IGM (REF 30205, LOT 1005897340). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED. THE PATIENT SAMPLE WAS NO LONGER AVAILABLE TO SUBMIT FOR EVALUATION. THE COMPLAINT TREND ANALYSIS FOUND NO TREND FOR THIS ISSUE. THE ANALYSIS OF THE BATCH HISTORY RECORDS FOR VIDAS CMV IGM BATCH 1005897340 /180621-0 AND VIDAS CMV IGM REFERENCE 30205-01 LOT 1005899440 / 180621-0 (MANUFACTURED AT THE SAME TIME, BUT PACKAGED FOR US MARKET) SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. THE COMPLAINT LABORATORY STUDIED THE CONTROL CHARTS : OF FIVE INTERNAL SAMPLES (TARGET : 0.31 - 0.97 - 0.55 - 1.27 TV). ON 12 VIDAS CMV IGM BATCHES, INCLUDING THE LOTS MENTIONED BY THE CUSTOMER (180621-0, 181229-0,190306-0 AND 190122-0). ALL THE SAMPLES WERE WITHIN SPECIFICATIONS. SINCE THE CUSTOMER'S SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, TESTING WAS PERFORMED ONLY ON INTERNAL SAMPLES, BUT WERE IMPOSSIBLE TO INTERPRET AS VIDAS CMV IGM BATCH 1005897340 /180621 0 WAS ALREADY EXPIRED WHEN THE CUSTOMER COMPLAINED. ACCORDING TO THE INFORMATION/DATA MENTIONED ABOVE, THE ROOT CAUSE ISN'T IDENTIFIED BECAUSE WE DIDN'T RECEIVE RETURN SAMPLE FROM THE CUSTOMER ,AND VIDAS CMV IGM REF 30205 BATCH 1005897340 /180621 0 WAS EXPIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT WHEN TESTING WITH VIDAS® CMV IGM (REF 30205, LOT 1005897340). THE CUSTOMER HAD RETESTED THREE PATIENT SAMPLES WITH NEW BATCHES OF CMV IGM. FOR ONE OF THE PATIENT SAMPLES, THE RESULT WITH THE NEW BATCHES OBTAINED POSITIVE RESULTS (1.06-1.22). THIS PATIENT SAMPLE HAD TESTED NEGATIVE WITH THE IMPACTED LOT ON (B)(6) 2017. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. ALTHOUGH PRODUCT REFERENCE 30205 IS NOT SOLD/DISTRIBUTED IN THE UNITED STATES, A SIMILAR PRODUCT IS (REFERENCE 30205-01). A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512540 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX SA 30205 1005897340

    Patients

    Seq Age Sex Outcome Treatment
    1