BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS CMV IGM 30 TESTS

    MDR report key: 11757735 · Received April 30, 2021

    Report

    Report Number
    8020790-2021-00116
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: THE ANALYSIS OF THE BATCH HISTORY RECORD OF VIDAS CMV IGM LOT 1008182270 / 210526-0 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. NO CUSTOMER'S SAMPLES AVAILABLE. THEREFORE, THE TESTS WERE PERFORMED ON INTERNAL SAMPLES AVAILABLE AT THE COMPLAINTS LABORATORY. AN ANALYSIS OF INTERNAL SAMPLES CONTROL CHARTS WAS PERFORMED ON THREE (3) INTERNAL SERA (TARGETS BETWEEN 0.69 TV AND 2.08 TV) ON FIVE (5) BATCHES INCLUDING THE LOT MENTIONED BY THE CUSTOMER. ALL VALUES WERE WITHIN SPECIFICATIONS AND THE CUSTOMER'S LOT WAS IN THE TREND OF THE OTHER LOTS. THE COMPLAINTS LABORATORY TESTED THREE (3) INTERNAL SAMPLES, 2 WITH POSITIVE TARGETS AND ONE (1) NEGATIVE ON THE RETAIN KIT VIDAS CMV IGM LOT 1008182270 / 210526-0. ALL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS, WITHOUT ANY INTERPRETATION CHANGE AND SIMILAR TO THOSE OBSERVED BEFORE THE BATCH RELEASE. NO DRIFT WAS NOTICED ON VIDAS CMV IGM LOT 1008182270 / 210526-0. ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED ON THE RETAIN KIT OF VIDAS CMV IGM LOT 1008182270 / 210526-0. THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE ISSUE OBSERVED BY THE CUSTOMER NAMELY A VIDAS CMV IGM NEGATIVE RESULT WHEN TESTING INTERNAL POSITIVE SAMPLES ON THE BATCH 1008182270 / 210526-0. FURTHER INVESTIGATION CANNOT BE PERFORMED WITHOUT THE CUSTOMER'S SAMPLES. THE CALIBRATION USED BY THE CUSTOMER FOR THESE PATIENT'S RESULTS WAS NOT VALID. AN ERROR WAS DISPLAYED ON THE VIDAS REPORT REGARDING AN INSUFFICIENT NUMBER OF STANDARD MEANING THAT AT LEAST ONE (1) S1 WAS MISSING OR OUT OF RANGE. IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS SARS CMV IGM REF. 30205 AT THE SECTION CALIBRATION. THE STANDARD, IDENTIFIED BY S1, MUST BE TESTED IN DUPLICATE (SEE USER MANUAL). THE STANDARD VALUE MUST BE WITHIN THE SET RFV (RELATIVE FLUORESCENCE VALUE) RANGE. IF THIS IS NOT THE CASE, RECALIBRATE. CONSEQUENTLY, THE CALIBRATION RESULTS ARE NOT CONSIDERED AS VALID AND THE PATIENT'S RESULTS SHOULD NOT BE REPORTED TO THE PHYSICIAN. ACCORDING TO THE DATA ABOVE, VIDAS® CMV IGM REF (B)(4) LOT 1008182270 / 210526-0 IS WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A (B)(6) RESULT WHILE PERFORMING PATIENT TESTING USING THE VIDAS® CMV IGM (REFERENCE # 30205, LOT # 1008182270, EXPIRY DATE: 26MAY2021). THE CUSTOMER IS USING A MINIVIDAS® INSTRUMENT (REFERENCE# (B)(4), SERIAL # (B)(4). THE CUSTOMER STATED THEY RECEIVED DISCREPANT RESULTS BETWEEN THE VIDAS® CMV IGM AND COBAS AND ARCHITECT METHODS FOR TWO SAMPLES FROM TWO SEPARATE PATIENTS. VIDAS® CMV IGM RESULTS: (B)(6). COBAS AND ARCHITECT RESULTS: (B)(6). PATIENT 1: (B)(4) (PREGNANT WOMAN) (B)(6) 2021. CMV IGM ARCHITECT: 3.43 (<0.85). CMV IGM MINI VIDAS: 0.06 RATIO (<0.7). CMV IGG ARCHITECT: 69.10 U/ML. CMV IGG AVIDITY: 0.12 RATIO (= LOW AVIDITY). THE CUSTOMER SENT THE SAMPLE TO ANOTHER LAB FOR CONFIRMATION. THE CUSTOMER NOTED A DELAY WITH THE MAXIMUM DELAY BEING ABOUT ONE DAY. THE CUSTOMER CONFIRMED THAT THE FALSE NEGATIVE RESULT WAS NOT REPORTED AND THAT THERE WAS ONLY A DELAY. EXTERNAL LAB: CMV IGM COBAS: 2.23 (<0.700) (B)(6). CMV IGM VIDAS: 1.510 (<0.699) (B)(6). PATIENT 2: (B)(4) (PATIENT WAS NOT PREGNANT). CMV IGM ARCHITECT: 1.34 RATIO (<0.85). CMV.IGM MINI VIDAS: 0.16 RATIO. CMV.IGG ARCHITECT: 99.00 U/ML. CMV COBAS: 3.70 (<0.700) (B)(6). IT SHOULD BE NOTED THAT THERE IS A POSSIBILITY OF CALIBRATION ISSUES AS THE CUSTOMER CONFIRMED THAT THERE MAY BE A STANDARD (S1) MISSING OR OUT OF RANGE. HOWEVER, THE PRINT OUT OF THE CALIBRATION CANNOT BE OBTAINED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED ANY PATIENT'S STATE OF HEALTH. NOTE: REFERENCE (B)(4) IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651048 VIDAS CMV IGM 30 TESTS VIDAS® CMV IGM 30 TESTS LKQ BIOMERIEUX SA 1008182270

    Patients

    Seq Age Sex Outcome Treatment
    1