BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10788305 · Received November 4, 2020

    Report

    Report Number
    1119779-2020-00909
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 14, 2020
    Report Date
    February 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA #: (B)(4) H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOT 0182253 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED 3 FALSE POSITIVE USING BD MAX¿ SYSTEMS KIT LOT 0182253 AND PROVIDED THE RUN FILE #101 FROM INSTRUMENT CT1600 FOR INVESTIGATION. ANALYSIS OF THE RUN #101 REVEALED THAT THERE ARE FOUR COV2 POSITIVE RESULTS IN THIS RUN: A03 (N2 POS), A11 (N2 POS), A12 (N1 POS) AND B02 (N1 AND N2 POS). NOT KNOWING WHICH SAMPLE WAS CONSIDERED A TRUE POS BY THE CUSTOMER, ALL FOUR SAMPLES WERE ANALYZED. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL POSITIVE RESULTS OF RUN #101. 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. EXAMINATION OF THE PCR CURVES ACROSS THE FOUR POSITIVE RESULTS IN RUN #101 RESULTED IN THREE SIGNAL PROFILES. THE FIRST PCR CURVE PATTERN SHOWED A STEP DISLOCATION IN THE RAW PCR SIGNAL AND GENERATED POSITIVE RESULTS (A03, N2 POSITIVE). THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE SECOND PCR CURVE PATTERN SHOWED A WEAK AND STEADY FLUORESCENCE INCREASE WHICH INDICATE PRESENCE OF LOW AMOUNT OF TARGET (A11 N2 POS). 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 THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. THE THIRD PCR CURVE PATTERN SHOWED ANOMALOUS FLUORESCENCE PATTERN WITH AN EARLY INCREASE OF THE FLUORESCENCE ASSOCIATED WITH A WEAK FLUCTUATING FLUORESCENCE SIGNAL (SAMPLES IN POSITIONS A12 N1 POS AND B02 N1-N2 POS). THIS PATTERN IS UNEXPECTED. EARLY CT INDICATES HIGH TARGET LOAD WHILE LOW FLUORESCENCE VALUES INDICATE LOW LOAD. MECHANISMS ASSOCIATED WITH THIS TYPE OF PATTERN COULD COME FROM VARIOUS SOURCES SUCH AS PRESENCE OF INHIBITORY SUBSTANCE IN THE SAMPLE OR FLUORESCENCE ANOMALY RELATED TO SYSTEM-INDUCED NOISE. THIS VERSION OF THE SARS-COV-2 ASSAY WAS LESS ROBUST TO SYSTEM-INDUCED NOISE AND THEREFORE MODIFICATIONS WERE MADE TO THE ASSAY (CUT-OFF CHANGE FOR N2 IN CONCERT WITH A CHEMISTRY MODIFICATION OF THE N1 AND N2 PROBES) TO REMEDIATE THIS ISSUE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD SARS-COV-2 LOT 0182253; HOWEVER, THIS LOT NUMBER INDICATES THAT THE CUSTOMER IS RUNNING A VERSION OF THE TEST THAT DOES NOT CONTAIN THE CHEMISTRY/CUT-OFF CHANGES AND NO LONGER MANUFACTURED. THE ROOT CAUSE WAS NOT IDENTIFIED FOR ALL DISCREPANT SAMPLES BUT TRUE POSITIVE SAMPLES, SAMPLES AT THE ASSAY LOD IS SUSPECTED FOR ONE POSITIVE RESULTS (LANE A11). HOWEVER, ONE PATTERN IDENTIFIED IN 2 SAMPLES (LANE A12 & B02) WAS PREVIOUSLY IDENTIFIED BY BD AS CONTRIBUTING TO FALSE POSITIVE RESULTS. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1632720 HAS ALREADY BEEN OPENED TO INVESTIGATE THE SYSTEM INDUCED FALSE POSITIVE EVENTS AND THE INVESTIGATION IDENTIFIED THE ROOT CAUSE AS HIGHER BACKGROUND FLUORESCENCE AND NON-ROBUST N2 CUT-OFF TO SYSTEM-INDUCED NOISE IN THE FIRST VERSION OF THE ASSAY. BOTH OF THESE ISSUES HAVE BEEN REMEDIATED IN THE AMENDED VERSION OF THE ASSAY. BD CONFIRMS THE COMPLAINT FOR 2 SAMPLES IN RUN FILE PROVIDED BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 3 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING A DIFFERENT TEST METHOD AND THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (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 WHILE TESTING FOR SARS COV-2 3 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING A DIFFERENT TEST METHOD AND THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252940 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 0182253

    Patients

    Seq Age Sex Outcome Treatment
    1