BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    MDR report key: 10226970 · Received July 2, 2020

    Report

    Report Number
    1119779-2020-00199
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 8, 2020
    Report Date
    August 10, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-129 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA REVIEW AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCT BY BD AND BIOGX SINCE LOT K20-129 WAS TESTED ALONG WITH THE BD MAX EXK TNA-3 LOT 0105545. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-129 LOT SHOWS THAT REAGENTS MET ALL PERFORMANCE CRITERIA AND TNA-3 LOT 0105545 WAS CONFORMING AND PASSED THE QC SPECIFICATIONS FOR RELEASE AND USE. THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS ON ONE PATIENT SAMPLE. THE SAMPLE FIRST GAVE A POSITIVE RESULT FOR N1 BUT WHEN RETESTED WITH A NEW COLLECTED SPECIMEN, IT GAVE A NEGATIVE RESULT. TWO RUNS PERFORMED ON BD MAX INSTRUMENT CT1348 WERE RECEIVED AND ANALYZED. RUN 662 WAS PERFORMED ON JUNE 6TH AND CONTAINED 3 SAMPLES TESTED WITH THE BIOGX SARS COV-2 ASSAY. ONE SAMPLE, TESTED IN A1, WAS THE ONLY ONE THAT GAVE A POSITIVE RESULT. CURVES ANALYSIS SHOWED NO AMPLIFICATION OF THE N2 TARGET (IN FAM, BOTTOM POSITION) WHEREAS A LATE BUT TRUE AMPLIFICATION WAS OBSERVED FOR THE N1 TARGET (IN FAM, TOP POSITION), WITH A CT VALUE OF 38.6 AND A EP OF 445, WHICH PASSED THE THRESHOLD VALUE TO BE CALLED POSITIVE. THE INITIAL FLUORESCENCE VALUES SHOWED NO ANOMALY AND EXPECTED EXPONENTIAL CURVE, CONFIRMING THAT THE CURVE OBTAINED FOR THE N1 TARGET WAS THE RESULT OF TRUE AMPLIFICATION. THE SAME SAMPLE WAS RETESTED IN RUN 671 BUT THE POSITION WAS NOT MENTIONED. THIS RUN WAS PERFORMED ON JUNE 8TH AND CONTAINED 11 SAMPLES TESTED WITH THE BIOGX SARS COV-2 ASSAY. ALL THE SAMPLES FROM THAT RUN GAVE A NEGATIVE RESULT AND THE CURVES SHOWED NO ANOMALY, AND NO LATE AMPLIFICATION OF THE N1 OR N2 TARGETS. THEREFORE, THE MOST LIKELY CAUSE OF THE DISCREPANT RESULTS IS THE PRESENCE OF SARS-COV-2 IN THE PATIENT SAMPLE, BUT AT LOW CONCENTRATION, NEAR THE LIMIT OF DETECTION OF THE BIOGX ASSAY AND WAS UNDETECTED WHEN TESTED IN RUN 671. ALSO, AN ISOLATED CONTAMINATION ISSUE COULD BE THE CAUSE OF THE DISCREPANT RESULTS. CUSTOMER QUESTIONED IF BLOODY SAMPLE COULD HAVE INTERFERED WITH THE PCR REACTION, CURRENT INDICATION FOR USE DOCUMENT FROM BIOGX DOES NOT LIST INTERFERING SUBSTANCES THUS IT IS NOT POSSIBLE TO PROVIDE AN ANSWER TO THE CUSTOMER. THE REAGENTS WERE NOT SUSPECTED TO BE IN CAUSE. THERE IS NO COMPLAINT TREND RELATED TO DISCREPANT RESULTS WITH THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM LOT K20-129. THE ROOT CAUSE WAS NOT FOUND. BIOGX AND BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BIOGX OR BD DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN (CAPA).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM DISCREPANT RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER REPORTS THE PATIENT WAS INITIALLY POSITIVE, AND UPON REPEAT WITH A NEW SPECIMEN, THE RESULT WAS NEGATIVE. ADDITIONAL INFORMATION WAS REQUESTED AND THE CUSTOMER STATED THE PATIENT WAS MOST LIKELY AT THE END OF INFECTION WHEN INITIALLY TESTED, AND UPON REPEAT PER THE PATIENTS FAMILY REQUEST THE PATIENT WAS AT THE NEGATIVE STAGE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM DISCREPANT RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER REPORTS THE PATIENT WAS INITIALLY POSITIVE, AND UPON REPEAT WITH A NEW SPECIMEN, THE RESULT WAS NEGATIVE. ADDITIONAL INFORMATION WAS REQUESTED AND THE CUSTOMER STATED THE PATIENT WAS MOST LIKELY AT THE END OF INFECTION WHEN INITIALLY TESTED, AND UPON REPEAT PER THE PATIENTS FAMILY REQUEST THE PATIENT WAS AT THE NEGATIVE STAGE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686599 BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other