BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® RUB IGG II

    MDR report key: 7403903 · Received April 6, 2018

    Report

    Report Number
    3002769706-2018-00050
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Report Date
    July 12, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFX
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED DUE TO THE SENSITIVITY (B22) FOR FIVE (5) SERA FROM A PREGNANT WOMAN WHEN USING VIDAS® RUB IGG II REFERENCE 30221 BATCH 1005974740/180911-1. FOUR (4) SERA WERE INTERPRETED EQUIVOCAL AND ONE (1) WAS INTERPRETED NEGATIVE WITH VIDAS, WHEREAS THEY WERE ALL INTERPRETED POSITIVE WITH CNR ENZYGNOST SIEMENS (WESTERN BLOT). TRENDING ANALYSIS: NO COMPLAINTS RECORDED ON VIDAS RUB IGG II REF 30221 BATCH 1005974740/180911-1 IN RELATION TO THE CUSTOMER'S COMPLAINT. NO NONCONFORMITY RECORDED ON VIDAS RUB IGG II REF 30221 LINKED TO THE CUSTOMER'S ISSUE. QUALITY CONTROL RECORDS: THE ANALYSIS OF THE BATCH HISTORY FOR VIDAS RUB IGG II BATCH 1005974740/180911-1 SHOWED NO ANOMALY DURING THE MANUFACTURING AND CONTROL PROCESSES. AN ANALYSIS OF INTERNAL SAMPLES CONTROL CHARTS, WAS CARRIED OUT ON FOUR (4) INTERNAL SERA WITH DIFFERENT CONCENTRATIONS (TARGET: 12 / 31 / 169 / 298 UI/ML) AND ON EIGHT (8) BATCHES INCLUDING THE BATCH MENTIONED BY THE CUSTOMER. ALL RESULTS WERE WITHIN SPECIFICATIONS. THE VIDAS RUB IGG II BATCH 1005974740/180911-1 IS IN TREND WHEN COMPARED TO OTHER BATCHES. TESTS PERFORMED INTERNALLY: FIVE (5) SERA (GEO, HUS, HUS, VER, NAV) WERE SUBMITTED BY THE CUSTOMER, AND WERE TESTED ON VIDAS RUB IGG II BATCHES 180911-1, AND TWO OTHER BATCHES,180607-0 AND 190411-0. THE RESULTS AND INTERPRETATION OBTAINED ON THE SERA WERE SIMILAR REGARDLESS OF WHICH BATCH WAS USED, EXCEPT FOR GEO IN WHICH THERE WAS NO INFORMATION REGARDING THE WESTERN BLOT. THE GEO SAMPLE WAS FOUND TO BE EQUIVOCAL WITH VIDAS RUB IGG II BATCHESA180607-0 AND 180911-1, AND NEGATIVE WITH BATCH 190411-0. THE DISCREPANCIES OBSERVED BETWEEN VIDAS AND THE COMPETITOR ARE NOT LINKED TO A SPECIFIC BATCH. DURING THE INVESTIGATION, SENSITIVITY FOR VIDAS RUB IGG II BATCH 1005974740/180911-1 WAS RECALCULATED AT 99.99% AND IS WITHIN THE EXPECTED PERFORMANCE RANGE (ACCORDING TO THE VIDAS RUB IGG II PACKAGE INSERT: THE SENSITIVITY OF THIS ASSAY IS BETWEEN 95.45 AND 100% DEPENDING ON THE POPULATION STUDIED). IN CONCLUSION, THE VIDAS RUB IGG II BATCH 1005974740/180911-1 IS WITHIN THE EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH VIDAS® RUB IGG II (REFERENCE 30221). THE PATIENT IS A PREGNANT WOMAN AND THE VACCINATED STATUS IS UNKNOWN. ONE SAMPLE WAS TAKEN AND THE TEST RESULT IS AS FOLLOWS: ON (B)(6) 2017: VIDAS® RUB IGG RESULT AT IU/ML -> NEGATIVE. ON (B)(6) 2018 COBAS® ROCHE RUB IGG TECHNIQUE RESULT AT 20.5 IU/ML -> POSITIVE (TESTED BY REFERENCE LABORATORY). ON (B)(6) 2018: NEW PATIENT SAMPLE TESTED WITH VIDAS®RUB IGGII IN DUPLICATE AND BOTH RESULTS WERE NEGATIVE. 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
    245448 VIDAS® RUB IGG II VIDAS® RUB IGG II LFX BIOMERIEUX SA 1005974740

    Patients

    Seq Age Sex Outcome Treatment
    1