BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 8275491 · Received January 24, 2019

    Report

    Report Number
    8020790-2019-00005
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A FALSE NEGATIVE RESULT WHEN TESTING A NEQAS QUALITY CONTROL SAMPLE WITH VIDAS® CMV IGM. THE CONCERNED EXTERNAL QUALITY ASSESSMENT (EQA) WAS UK NEQAS LOT 4473 CMV SEROLOGY OF 22.10.2018 SAMPLE 4965 (PILOT STUDY). THE CUSTOMER DID NOT SUBMIT THE SAMPLE FOR EVALUATION. COMPLAINT TRENDING ANALYSIS: NO OTHER COMPLAINT FOR THE EXTERNAL QUALITY CONTROL ISSUE WAS RECORDED ON VIDAS CMV IGM REFERENCE 30205 BATCH 1006463790/190306-0. NO OTHER COMPLAINT RECORDED ABOUT THE SAME EXTERNAL QUALITY CONTROL (UK NEQAS LOT 4473 CMV SEROLOGY OF 22.10.2018 SAMPLE 4965 (PILOT STUDY) ON VIDAS CMV IGM REFERENCE 30205 A REVIEW OF PRODUCTION RECORDS CONFIRMED THERE WAS NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. CONTROL CHARTS ANALYSIS: ANALYSIS WAS PERFORMED ON FOUR (4) INTERNAL SAMPLES (3 POSITIVE WITH TARGET : 1.27 - 1.84 - 1.19 TV AND 1 NEGATIVE WITH TARGET : 0.54 TV), ON SEVEN (7) BATCHES OF VIDAS CMV IGM (INCLUDING CUSTOMER LOT 1006463790/190306-0). ALL THE RESULTS WERE WITHIN SPECIFICATIONS AND VIDAS CMV IGM LOT 1006463790/190306-0 WAS IN THE TREND OF THE OTHER LOTS. TESTS PERFORMED : TESTING INCLUDED THREE (3) INTERNAL POSITIVE SAMPLES AND ONE (1) NEGATIVE INTERNAL SAMPLE (THE SAME AS THOSE MENTIONED ABOVE), ON THE RETAINED KIT OF VIDAS CMV IGM 1006463790/190306-0. ALL THE INTERNAL SAMPLE'S RESULTS WERE WITHIN SPECIFICATIONS AND SIMILAR TO THOSE OBTAINED BEFORE THE BATCH RELEASE. THERE WAS NO DRIFT OF THE BATCH SINCE ITS RELEASE. CONCLUSION: THE QUALITY CONTROL SAMPLE WAS NOT RECEIVED FOR INVESTIGATION, SO ONLY AN ASSUMPTION CAN BE MADE THAT THE POSITIVE RESULT COULD BE LINKED TO ANTIBODIES OR SUBSTANCES IN THE QC SAMPLE, THAT INTERFERE WITH ONE OF THE REAGENT COMPONENTS. AS MENTIONED IN THE VIDAS CMV IGM PACKAGE INSERT, INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED AS PART OF A COMPLETE CLINICAL PROFILE. ACCORDING TO THE ALL ABOVE DATA, VIDAS CMV IGM REFERENCE 30205 BATCH 1006463790/190306-0 IS WITHIN EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT WHEN TESTING A NEQAS QUALITY CONTROL SAMPLE WITH VIDAS® CMV IGM. THE EXPECTED VALUE OF THE SAMPLE NUMBER (B)(6) WAS POSITIVE, BUT THE CUSTOMER OBTAINED A NEGATIVE VALUE (0.69 TV). AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO 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
    67692 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX SA 1006463790

    Patients

    Seq Age Sex Outcome Treatment
    1