BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 7666722 · Received July 6, 2018

    Report

    Report Number
    3002769706-2018-00098
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Report Date
    September 19, 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

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN FRANCE THAT REPORTED OBTAINING EQUIVOCAL AND FALSE NEGATIVE RESULTS WHEN TESTING THEIR INTERNAL QUALITY CONTROL (IQC) VIROTROL® TORCH-M SAMPLE WITH A NEW BATCH OF VIDAS® CMV IGM, LOT 1005897340. IN SPITE OF THE DISCREPANT RESULTS, THE NEW BATCH WAS IMPLEMENTED 21-OCT-2017. THE CUSTOMER'S RESULTS WERE THE FOLLOWING: MAR2017-OCT2017 ON PREVIOUS LOT (NOT KNOWN)) OF VIDAS CMVM. MEANS: 0.98. ET: 0.10. CV: 10.20%. 2ET: 0.78 - 1.18. 3 ET: 0.68- 1.28. 21OCT2017: TO DATE WITH LOT CMVM 1005897340/180621-0 12 VALUES: 0.73/0.70/0.68/0.73/0.79/0.79/0.81/0.71/0.73/0.59/0.59/0.63. MEANS: 0.68. ET: 0.08. PATIENT SAMPLES WERE TESTED BY THE CUSTOMER LAB AND THE RESULTS WERE COMPLIANT BETWEEN BOTH BATCHES. RESULT CMVM WITH PREVIOUS LOT : I = 1.36 => POSITIVE INTERPRETATION. RESULT CMVM WITH LOT 1005897340/180621-0 : I = 1.2 => POSITIVE INTERPRETATION. BATCH HISTORY RECORDS AND TREND ANALYSIS: NO NON-CONFORMITY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES LINKED TO THE CUSTOMER ISSUE. THE RESULTS OF FIVE (5) INTERNAL SERA WERE STUDIED ON THE LOT 1005897340/180621-0 COMPARED TO SIX (6) OTHER VIDAS CMVM LOTS: THE RESULTS OBTAINED ON LOT 1005897340/180621-0 WERE WITHIN SPECIFICATIONS AND WITHIN THE TREND COMPARED TO THE ONES OBTAINED ON OTHER LOTS. AFTER THE MANUFACTURING OF 1005897340/180621-0, ACTIONS WERE IMPLEMENTED THAT INCLUDED A NEW INSTRUMENT FOR SONICATION AND NEW ALIQUOT OF INTERNAL SERA). ALL LOTS MANUFACTURED ARE CURRENTLY FOLLOWED UP USING AN ADDITIONAL CONTROL IN ORDER TO CHECK THE EFFICIENCY OF THE IMPROVEMENT. COMPLAINT TRENDING SHOWED THERE WAS NO OTHER COMPLAINT FOR THIS ISSUE ON VIDAS CMV IGM REF 30202 BATCH 1005897340/180621-0. TESTS PERFORMED INTERNALLY: THE LOT VIDAS CMVM 1005897340/ 180621-0 IS NOW EXPIRED, IT WAS NOT POSSIBLE TO RETEST IT. ADDITIONAL DATA / INFORMATION, HYPOTHESIS AND CONCLUSION: THIS IQC IS CLOSED TO THE CUT-OFF AND CAN BE DISTRIBUTED ALL AROUND THE THRESHOLD TARGET : 0.98 ACCEPTABLE RANGE WITHIN 2 SD: [0.78-1.18] : INTERPRETATION FROM EQUIVOCAL TO POSITIVE. ACCEPTABLE RANGE WITHIN 3 SD: [0.68-1.28] : INTERPRETATION FROM NEGATIVE TO POSITIVE. THAT MEANS STATISTICALLY, THE RESULTS CAN BE OUT OF RANGE WITH A NEGATIVE INTERPRETATION (I < 0.70). THE DIFFERENCES OBSERVED ARE LINKED TO THE NORMAL INTER-LOT VARIABILITY WHICH HAS NO IMPACT ON PATIENT RESULT OR INTERPRETATION STATUS. THIS IQC VIROTROL IS MANUFACTURED (NOT NATURAL SAMPLE) AND MANUFACTURING PROCESS CAN AFFECT SAMPLE MATRIX. SO THIS SAMPLE COULD BEHAVE DIFFERENTLY FOLLOWING SOME LOTS OF VIDAS CMVM. THE CUSTOMER RE-RAN PATIENT SAMPLES PREVIOUSLY FOUND POSITIVE USING ANOTHER BATCH AND THE RESULTS ARE SIMILAR: NO IMPACT ON PATIENTS SAMPLES. IT'S CONFIRMED BY THE CONTROL CHART ANALYSIS THAT SHOWED THAT QC OBTAINED ON THIS LOT ARE IN THE TREND OF THOSE OBTAINED ON OTHER LOTS. FINALLY, IT IS RECOMMENDED THAT EACH LABORATORY ESTABLISHES ITS OWN RANGE FOR EACH ANALYTE (EXTRACT FROM PACKAGE INSERT VIROTROL TORCH-M).

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING EQUIVOCAL AND FALSE NEGATIVE RESULTS WHEN TESTING THEIR INTERNAL QUALITY CONTROL (IQC) VIROTROL® TORCH-M SAMPLE WITH A NEW BATCH OF VIDAS® CMV IGM, LOT 1005897340. IN SPITE OF THE DISCREPANT RESULTS, THE NEW BATCH WAS IMPLEMENTED 21-OCT-2017. THE IQC FUNCTIONED AS INTENDED BY SENDING A WARNING TO THE CUSTOMER. THE CUSTOMER CHECKED THE RESULTS AND FOUND NO IMPACT TO PATIENT SAMPLES. 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. THERE WAS NO PATIENT ASSOCIATED WITH THIS DISCREPANT QUALITY CONTROL RESULT. 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
    509183 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX SA 30205

    Patients

    Seq Age Sex Outcome Treatment
    1