BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10812055 · Received November 9, 2020

    Report

    Report Number
    1119779-2020-00949
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    October 14, 2020
    Report Date
    February 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 OF THE BD MAX SARS-COV-2 REAGENTS INDICATED THAT THE LOT 0182253 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE CUSTOMER COMPLAINED ABOUT ONGOING FALSE POSITIVE (DISCREPANT) RESULT WHILE USING BD MAX SARS-COV-2 REAGENTS, DESPITE THE UDP MODIFICATIONS MADE ON 2020-10-01. IN 2 DAYS, 7 OUT OF 11 SARS-COV-2 POSITIVE RESULTS WERE REPEATED WITH 2 OTHER ASSAYS AND THEY GAVE NEGATIVE RESULTS. CUSTOMER PROVIDED 6 RUNS CONTAINING POSITIVE RESULTS FROM INSTRUMENT CT0711 AND TABLE WITH LIST OF 10 SAMPLES FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD MAX SARS-COV-2 REAGENTS PACKAGE INSERT INSTRUCTION FOR USE. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE 10 DISCREPANT RESULTS (10 SAMPLES INVESTIGATED: #638/A10, #639/B1, #639/B4, #639/B7, #639/B10, #641/B5, #641/B7, #643/B2, #644/A11, #644/B12). 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 10 SAMPLES RESULTED IN FOUR SIGNAL PROFILES. THE FIRST CURVES PATTERN WAS OBSERVED ON THREE SAMPLES #639/B1, #643/B2, #644/B12. THE CURVES SHOW NO AMPLIFICATION OF ANY TARGET AND ABNORMAL LOW FLUORESCENCE VALUES IN RAW SIGNAL. A PUNCTUAL ISSUE FROM AN UNKNOWN ORIGIN IS SUSPECTED. BD WAS UNABLE TO FIND THE EXACT CAUSE OF THESE CURVES BUT UNRESOLVED RESULT WAS THE EXPECTED RESULT IN THOSE CONDITIONS. THESE SAMPLES ARE NOT DISCREPANT. THE SECOND CURVES PATTERN WAS OBSERVED ON THREE SAMPLES #638/A10, #641/B5 AND #641/B7. THE CURVES SHOW TRUE AMPLIFICATION, WITHOUT ANOMALY. MOREOVER, THESE POSITIVE RESULTS WERE CONFIRMED BY THE CUSTOMER¿S TWO REFERENCE METHODS. NO DISCREPANT RESULT WAS THUS OBTAINED FOR THESE SAMPLES EITHER. THE THIRD CURVES PATTERN WAS OBSERVED ON TWO SAMPLES #639/B10 AND #644/A11. 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 FIND THE CAUSE OF THESE ATYPICAL CURVES. FINALLY, THE LAST CURVES PROFILE, OBSERVED FOR TWO SAMPLES #639/B4 AND #639/B7, 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 0182253; 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 DISCREPANT RESULTS HOWEVER, ONE PATTERN IDENTIFIED IN 2 SAMPLES WAS PREVIOUSLY IDENTIFIED BY BD AS CONTRIBUTING TO FALSE POSITIVE RESULTS. CAPA#1632720 HAS ALREADY BEEN OPENED 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 7 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. TESTS WERE REPEATED USING BD BIOGX COVID ASSAY AND CEPHEID AND THE RESULTS WERE NEGATIVE. RESULTS WERE NOT REPORTED AND THERE WAS NO PATIENT IMPACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 7 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. TESTS WERE REPEATED USING BD BIOGX COVID ASSAAY AND CEPHEID AND THE RESULTS WERE NEGATIVE. RESULTS WERE NOT REPORTED AND THERE WAS NO PATIENT IMPACT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276984 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1