BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11631744 · Received April 7, 2021

    Report

    Report Number
    1119779-2021-00620
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 2, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K21-088 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX SINCE DATA ANALYSIS REVEALED THAT THE KIT BIOGX SARS-COV-2 OSR WAS TESTED USING THE EXTRACTION KIT BD MAX EXK TNA-3 LOT 1005832. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-633 LOT PERFORM AS EXPECTED AND MEET BIOGX PERFORMANCE CRITERIA. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX EXK TNA-3 LOTS 1005832 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT A PATIENT SAMPLE THAT GAVE DISCREPANT RESULTS UPON REPEAT WITH THE BD BIOGX SARS-COV-2 OSR FOR BD MAX¿ SYSTEM KIT LOT K21-088. CUSTOMER PROVIDED TWO RUN FILES (RUNS 1521 AND 1525) FOR INVESTIGATION. ACCORDING TO THE COMPLAINT TEXT, THE SAMPLES WERE COLLECTED IN REMEL M4RT MEDIA WHICH IS AN OFF-LABEL USE OF THIS PRODUCT. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENTS PACKAGE INSERT INSTRUCTION FOR USE. IN THE INITIAL TEST, ONE PATIENT SAMPLE WAS POSITIVE FOR BOTH N1 AND N2 TARGETS, BUT WHEN RECOLLECTED AND REPEATED IT WAS NEGATIVE LESS THAN 24 HOURS LATER. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE DISCREPANT RESULTS OBTAINED IN THESE TWO RUNS. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL POSITIVE RESULTS. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. ANALYSIS OF THE PCR CURVES FOR POSITIVE RESULTS IN RUN #1521, SHOW LOW, LATE BUT TRUE AMPLIFICATION FOR N1 AND N2 TARGETS. ANALYSIS OF THE PCR CURVE IN RUN #1525 SHOW NO AMPLIFICATION FOR BOTH TARGETS. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. ACCORDING TO THE COMPLAINT TEXT, THE PATIENT PRESENTED RELATED SYMPTOMS. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BIOGX SARS-COV-2 OSR LOT K21-0888. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. SAMPLE WAS RECOLLECTED AND RETESTED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT POSITIVE RESULT FOR THE COV-2 ASSAY. CUSTOMER HAS SENT THE RUN DATA FOR THE DISCREPANT RESULTS: (B)(6). PATIENT SAMPLE WAS NOT REPEATED A THIRD TIME (ORIGINALLY THIS WAS THE INTENTION OF THE LAB). CUSTOMER PROBLEM: CUSTOMER REPORTING A DISCREPANT RESULT ON THE BD MAX COV-2 BIOGX ASSAY, LOT# K21-088, OCCURRING ON (B)(6) 2021. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING; CUSTOMER OBTAINED A POSITIVE RESULT (N1 AND N2) ON THE PATIENT INITIALLY. THE SAMPLE WAS RECOLLECTED AND REPEATED AND THE SECOND RESULT WAS NEGATIVE. THE SAMPLE WAS REPEATED UNDER 24 HOURS LATER. SPECIMEN WAS COLLECTED IN REMEL M4RT MEDIA BOTH TIMES. THE PATIENT WAS SYMPTOMATIC.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. SAMPLE WAS RECOLLECTED AND RETESTED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT POSITIVE RESULT FOR THE COV-2 ASSAY. CUSTOMER HAS SENT THE RUN DATA FOR THE DISCREPANT RESULTS: RUN 1521 SAMPLE A3 ACCESSION# (B)(4)-PATIENT SAMPLE WAS POSITIVE FOR N1 AND N2 (B)(6) 2021 AM. RUN 1525 SAMPLE A10 ACCESSION# (B)(4)-SAME PATIENT, NEW SAMPLE COLLECTED AND REPEATED-NEGATIVE (B)(6) 2021 PM. PATIENT SAMPLE WAS NOT REPEATED A THIRD TIME (ORIGINALLY THIS WAS THE INTENTION OF THE LAB). CUSTOMER PROBLEM: CUSTOMER REPORTING A DISCREPANT RESULT ON THE BD MAX COV-2 BIOGX ASSAY, LOT# K21-088, OCCURRING ON (B)(6) 2021. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING; CUSTOMER OBTAINED A POSITIVE RESULT (N1 AND N2) ON THE PATIENT INITIALLY. THE SAMPLE WAS RECOLLECTED AND REPEATED AND THE SECOND RESULT WAS NEGATIVE. THE SAMPLE WAS REPEATED UNDER 24 HOURS LATER. SPECIMEN WAS COLLECTED IN REMEL M4RT MEDIA BOTH TIMES. THE PATIENT WAS SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526236 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K21-088

    Patients

    Seq Age Sex Outcome Treatment
    1