BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MEASLES IGG

    MDR report key: 6189139 · Received December 20, 2016

    Report

    Report Number
    3002769706-2016-00525
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Report Date
    November 30, 2016
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    LJB
    PMA / PMN Number
    CL I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE (B)(6)NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH THE VIDAS MEASLES IGG (REFERENCE 30219) RELATED TO FALSE NEGATIVE RESULTS INVOLVING A (B)(6) SAMPLE (DISTRIBUTION (B)(6) / SPECIMEN (B)(6)). THE CUSTOMER REPORTED THE SAMPLE WAS TESTED ON THEIR PRIMARY TESTING PLATFORM (NOVATEC), WHICH IDENTIFIED THE SAMPLE AS POSITIVE. THE CUSTOMER INDICATED THAT SUBSEQUENT TESTING OF THE SAMPLE VIA VIDAS OBTAINED A RESULT OF EQUIVOCAL (0.53, <0.5 WOULD BE NEGATIVE). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE THRESHOLDS AND INTERPRETED RESULTS FOR VIDAS MEASLES IGG ASSAY ARE THE FOLLOWING: < 0.50 NEGATIVE, - 0.50 TO < 0.70 EQUIVOCAL, - 0.70 POSITIVE. THE EXTERNAL QUALITY ASSESSMENT "EQA MSG 3401 FROM (B)(6) DISTRIBUTION (B)(6)" INDICATES THAT 88% OF THE PARTICIPANTS WHO USED VIDAS MEASLES IGG (MSG) REF.30219 OBTAINED EQUIVOCAL OR NEGATIVE RESULTS, THOUGH IT WAS EXPECTED TO BE POSITIVE. THREE (3) SIMILAR COMPLAINTS WERE RECORDED FOR DISCREPANT RESULTS USING TWO (2) DIFFERENT VIDAS MSG BATCHES. - VIDAS MSG LOT 1004949820 (170430-0) GAVE AN EQUIVOCAL RESULT (0.68 TV) ((B)(4)). - VIDAS MSG LOT 1004802610 (170302-0) GAVE AN EQUIVOCAL RESULT (0.53 TV) ((B)(4)) AND A NEGATIVE RESULT (0.48 TV) ((B)(4)). ANALYSIS OF THE ASSOCIATED BATCH HISTORY RECORDS SHOWS NO ANOMALY DURING THE MANUFACTURING AND CONTROL PROCESSES. THE BIOMÉRIEUX QUALITY PRODUCT LABORATORY STUDIED THE CONTROL CHARTS OF SIX (6) INTERNAL SAMPLES (TARGET : 0.2 VT, 0.17 VT, 3.09 VT, 4.81 VT, 1.59 VT AND 0.31 VT) WITH EIGHT (8) DIFFERENT BATCHES OF VIDAS® MSG INCLUDING THE TWO (2) CUSTOMER BATCHES: ALL RESULTS WERE WITHIN SPECIFICATIONS. THE QUALITY PRODUCT LABORATORY ALSO TESTED THE SIX (6) INTERNAL SAMPLES WITH VIDAS® MSG LOTS 170302-0 AND 170430-0. THE RESULTS WERE SIMILAR TO THOSE OBTAINED DURING THE RELEASE OF THE BATCHES CONFIRMING THAT THERE IS NO EVOLUTION OF THE VIDAS MSG LOTS 170302-0 AND 170430-0. THE QUALITY PRODUCT LABORATORY TESTED THE SPECIMEN 3401 FROM (B)(6) DISTRIBUTION (B)(6) WITH VIDAS MSG LOT 170302-0, LOT 170430-0 AND AN ADDITIONAL BATCH 170622-0 (BATCH MANUFACTURED WITH DIFFERENT CRITICAL RAW MATERIAL) AND OBTAINED THE FOLLOWING RESULTS: - VIDAS MSG LOT 170302-0 ; SAMPLE 3401 : 0.47 TV (584 RFV ) NEGATIVE INTERPRETATION CUSTOMERS' RESULTS: 0.53 TV NEGATIVE INTERPRETATION AND 0.58 VT EQUIVOCAL INTERPRETATION THE CUSTOMER'S RESULTS AND RESULTS OBTAINED AT THE QUALITY PRODUCT LABORATORY ARE VERY CLOSE FROM THE EQUIVOCAL LOWER ZONE (0.5 TV) FOR THIS SAMPLE AND ARE REPRODUCIBLE BETWEEN THEMSELVES. IT'S WRITTEN IN THE IFU THAT "EQUIVOCAL SAMPLES SHOULD BE REPEATED WITH A FRESH SPECIMEN". - VIDAS MSG LOT 170430-0 ; SAMPLE 3401 : 0.66 TV (900 RFV ) EQUIVOCAL INTERPRETATION CUSTOMERS' RESULTS: 0.68 TV EQUIVOCAL INTERPRETATION THE CUSTOMER'S RESULTS AND RESULTS OBTAINED AT THE QUALITY PRODUCT LABORATORY ARE REPRODUCIBLE BETWEEN THEMSELVES. IT'S WRITTEN IN THE IFU THAT "EQUIVOCAL SAMPLES SHOULD BE REPEATED WITH A FRESH SPECIMEN". - VIDAS MSG LOT 170622-0 ; SAMPLE 3401 : 0.92 TV (1249 RFV) POSITIVE INTERPRETATION . EXTERNAL QUALITY CONTROLS ARE MANUFACTURED SAMPLES AND NOT NATURAL SAMPLES FROM PATIENTS. MANUFACTURING PROCESS CAN AFFECT SAMPLE MATRIX. NO INFORMATION WAS RECEIVED FROM (B)(6) REGARDING THE MANUFACTURING OF THIS EXTERNAL QUALITY CONTROL. WITHOUT THIS INFORMATION, IT'S NOT POSSIBLE TO INVESTIGATE FURTHER. FURTHERMORE, INTERNAL SAMPLES CLOSE FROM THE EQUIVOCAL ZONE HAVE BEEN TESTED ON THESE THREE (3) LOTS DURING THE QUALITY CONTROL OF THESE LOTS AND ALL GAVE THE COMPLIANT INTERPRETATION, NO INTERPRETATION CHANGE WAS OBSERVED FROM BATCH TO BATCH. BASED ON THE COMPLAINT TREND ANALYSIS, ON THE RESULTS OBTAINED ON SIX (6) INTERNAL SAMPLES RETESTED, ON THE RESULTS OBTAINED ON THE SPECIMEN 3401 FROM (B)(6)DISTRIBUTION (B)(6) WHICH ARE CLOSE FROM THE EQUIVOCAL LOWER ZONE OR WITHIN THE EQUIVOCAL ZONE AND ON THE FACT THAT NO INFORMATION WAS RECEIVED FROM (B)(6) REGARDING THE MANUFACTURING OF THIS EXTERNAL QUALITY CONTROL, THE INVESTIGATION CONCLUDES THAT PERFORMANCE OF VIDAS MSG LOTS 170302-0 AND 170430-0 ARE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH THE VIDAS® MEASLES IGG (REFERENCE (B)(4)) RELATED TO FALSE NEGATIVE RESULTS INVOLVING A NEQAS SAMPLE ((B)(6)). AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842322 VIDAS® MEASLES IGG VIDAS® MEASLES IGG LJB BIOMERIEUX, S.A. 1004802610

    Patients

    Seq Age Sex Outcome Treatment
    1