BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11030458 · Received December 17, 2020

    Report

    Report Number
    1119779-2020-01247
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 4, 2020
    Report Date
    February 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 445003) LOT 0125173 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM LOT 0125173 WAS USED IN COMBINATION WITH THREE BD MAX¿ EXK¿ TNA-3 EXTRACTION KIT LOTS (0168394, 0175080 & 0231389). HOWEVER, IT IS NOT POSSIBLE TO KNOW WHICH BD SARS-COV-2 REAGENTS LOT WAS LINKED TO EACH SAMPLE. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX¿ EXK¿ TNA-3 INDICATED THAT LOTS 0168394, 0175080 & 0231389 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX SARS-COV-2 REAGENTS INDICATED THAT THE LOT 0125173 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED POSITIVE RESULTS ON SAMPLES WHEN TESTED WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM, WHICH WERE NEGATIVE WHEN TESTED WITH THEIR REFERENCE METHOD (ROCHE COBAS AND HOLOGIC PANTHER PLATFORM). CUSTOMER PROVIDED THE RUNS CONTAINING 15 FALSE POSITIVE RESULTS AND THE DATABASES OF INSTRUMENTS CT0629 AND CT0909 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE 15 DISCREPANT RESULTS (15 SAMPLES INVESTIGATED: (B)(6)). 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 15 SAMPLES RESULTED IN THREE SIGNAL PROFILES. THE FIRST CURVES PATTERN WAS OBSERVED ON SAMPLES (B)(6) . THE CURVES SHOW AMPLIFICATIONS FOR N1 OR / AND N2 TARGETS WITHOUT ANOMALY, INDICATIVE OF TRUE POSITIVE RESULTS. OVERALL, THESE SAMPLES APPEAR TO BE TRUE LOW POSITIVES. 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 SECOND CURVES PATTERN WAS OBSERVED ON SAMPLES (B)(6) . THE CURVES SHOW A STEP DISLOCATION IN THE RAW PCR SIGNAL AND GENERATE POSITIVE RESULTS. HOWEVER, THIS TYPE OF CURVE DOES NOT CORRESPOND TO TRUE AMPLIFICATION. THERE ARE VARIOUS POTENTIAL CONTRIBUTORS THAT COULD LEAD TO THIS TYPE OF CURVE. BD WAS UNABLE TO CONFIRM THE CAUSE OF THESE ATYPICAL CURVES. FINALLY, THE THIRD CURVES PROFILE, OBSERVED FOR SAMPLES (B)(6) , SHOW A PATTERN THAT IS CAUSED BY SYSTEM-INDUCED NOISE. THIS VERSION OF THE ASSAY WAS NOT 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 PROBE) TO REMEDIATE THIS ISSUE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD SARS-COV-2 LOT 0125173; HOWEVER, THIS LOT NUMBER INDICATES THAT THE CUSTOMER IS RUNNING A VERSION OF THE ASSAY THAT DOES NOT CONTAIN THE CHEMISTRY/CUT-OFF CHANGES AND NO LONGER MANUFACTURED. THE ROOT CAUSE WAS NOT IDENTIFIED FOR ALL DISCREPANT SAMPLES. ONE PATTERN IDENTIFIED IN 2 SAMPLES WAS PREVIOUSLY IDENTIFIED BY BD AS CONTRIBUTING TO FALSE POSITIVE RESULTS. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1632720 HAS ALREADY BEEN OPEN TO INVESTIGATE THE SYSTEM INDUCED N2 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 PROVIDED IN THE DATABASE PROVIDED BASED ON THE INVESTIGATION THAT WAS PERFORMED. ACTIONS HAVE BEEN IMPLEMENTED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 38 FALSE POSITIVE RESULTS WERE OBTAINED DURING A TWO WEEK PERIOD. SPECIMENS WERE REPEATED USING ROCHE COBAS AND HOLGIC PANTHER AND THE RESULTS WERE NEGATIVE. ALL POSITIVE RESULTS ARE SENT OUT FOR CONFIRMATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: 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). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0112137. MEDICAL DEVICE EXPIRATION DATE: 2020-11-06 . DEVICE MANUFACTURE DATE: 2020-04-21. MEDICAL DEVICE LOT #: 0125173. MEDICAL DEVICE EXPIRATION DATE: 2020-11-06. DEVICE MANUFACTURE DATE: 2020-05-04. MEDICAL DEVICE LOT #: 0133358. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: 2020-05-12. MEDICAL DEVICE LOT #: 0133366. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 38 FALSE POSITIVE RESULTS WERE OBTAINED DURING A TWO WEEK PERIOD. SPECIMENS WERE REPEATED USING ROCHE COBAS AND HOLGIC PANTHER AND THE RESULTS WERE NEGATIVE. ALL POSITIVE RESULTS ARE SENT OUT FOR CONFIRMATION. 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
    1496040 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1