BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11382042 · Received February 25, 2021

    Report

    Report Number
    1119779-2021-00392
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 3, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-633 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 LOTS 0302011 AND 1012578. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-633 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX EXK TNA-3 LOTS 0302011 AND 1012578 INDICATED THAT THE LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT SUSPECTED FALSE POSITIVE RESULTS. ACCORDING TO THE CUSTOMER, ALL SAMPLES WERE RETESTED WITH AN IN-HOUSE PCR TEST (CEPHEID) AND 50% OF THEM GAVE NEGATIVE RESULTS. CUSTOMER PROVIDED FIVE RUN FILES (RUNS 776, 814, 857, 859 AND 877) FOR INVESTIGATION. 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. 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 SHOWS LATE AND LOW BUT TRUE AMPLIFICATIONS FOR EITHER N1 OR N2 TARGETS WITHOUT ANOMALY. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. IN TWO OF THE RUNS PROVIDED BY THE CUSTOMER (814 AND 857), THERE WAS STRONG N1/N2 POSITIVE PATIENT SAMPLES SUPPORTING THE POSSIBILITY OF CROSS CONTAMINATION DURING SAMPLE PREPARATION. 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 K20-633. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. CONFIRMATORY TESTING WAS PERFORMED USING A CEPHEID TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. CONFIRMATORY TESTING WAS PERFORMED USING A CEPHEID TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277112 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K20-633

    Patients

    Seq Age Sex Outcome Treatment
    1