BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 12028872 · Received June 18, 2021

    Report

    Report Number
    1119779-2021-01021
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 22, 2021
    Report Date
    August 27, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOT 1026980 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 LOT 1026980 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED FALSE POSITIVE RESULTS FOR 2 SAMPLES FROM THE (B)(6), TESTED WITH THE BD SARS-COV-2 REAGENTS KIT, AS WELL AS AN INCREASED NUMBER OF TESTS WITH ATYPICAL CURVES IN WHICH ONLY 1 GENE IS AMPLIFIED, WHEN USING LOT 1026980. CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT (B)(4) AS WELL AS PDF FILES OF RUNS MENTIONED IN THE COMPLAINT (RUN 879, 880, 916) FOR THE INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENTS INSTRUCTION FOR USE. ANALYSIS OF THE CUSTOMER¿S DATABASE REVEALED A TOTAL OF 10 894 SAMPLES TESTED WITH THE BD SARS-COV-2 REAGENT KIT SINCE THE BEGINNING OF USE BETWEEN (B)(6) 2020 AND (B)(6) 2021. ANALYSIS OF THIS PERIOD SHOWS FLUCTUATIONS IN THE OVERALL RATE OF POSITIVE RESULTS WITH NO ABNORMAL INCREASE. THIS IS ALSO TRUE FOR SAMPLES WITH ONLY N1 TARGET POSITIVE RESULTS. ANALYSIS BY KIT LOT, AS WELL AS BY DIFFERENT INSTRUMENTS, REVEALED NO ISSUE. MANUAL PCR CURVE ADJUDICATION OF ALL THE SUSPECTED FALSE N1 POSITIVE SAMPLES IDENTIFIED BY THE CUSTOMER (SAMPLES: RUN 879/POSITION A1, RUN 880/ POSITIONS B2, B6 & B10 AND RUN 916/POSITION A6) REVEALED LATE AND LOW N1 TARGET ONLY, BUT TRUE, POSITIVE RESULTS. AS MENTIONED IN THE PACKAGE INSERT, DETECTION OF ONE OR BOTH TARGETS (N1 AND/OR N2) IS CONSIDERED POSITIVE. 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. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX SARS-COV-2 REAGENTS LOT 1026980. THE ROOT CAUSE WAS NOT IDENTIFIED BUT SPECIMENS AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE ARE SUSPECTED. NO PRODUCT ISSUE IS SUSPECTED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM 4 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING REPEATED BY BD MAN AND SEEGENE AND BOTH WERE NEGATIVE. THE RESULTS WERE REPORTED TO PHYSICIANS. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVIDENCE OF NON-CONCORDANT RESULTS IN SAMPLES FROM THE PUBLIC HEALTH LABORATORY EVALUATIVE PANEL FOR THE BD MAX SARS COV-2 TEST THAT WERE REPORTED WITH A POSITIVE RESULT AND CORRESPONDED TO NEGATIVE SAMPLES. CUSTOMER ALSO REPORTED AN INCREASED NUMBER OF TESTS WITH ATYPICAL CURVES, IN WHICH ONLY 1 GENE IS AMPLIFIED AND THE TEAM INTERPRETS "POSITIVE" ¿ WITHIN THIS GROUP OF SAMPLES, THE LSPD EVALUATIVE PANEL AND SOME PATIENT SAMPLES HAVE BEEN REPORTED. ¿ SAMPLE (B)(6) GAVE THE FALSE POSITIVE PATTERN, IT WAS REPEATED BY BD MAX AND SEEGENE AND BY BOTH PLATFORMS IT WAS CONFIRMED NEGATIVE. ¿ A REVISION OF THE REAGENT LOT NUMBER WAS CARRIED OUT AND IT WAS EVIDENCED THAT WITH LOT # 1026980, THERE WAS A DOUBLE INCREASE IN REPETITION THAN THAT OBSERVED WITH LOTS 1026935 AND 1012622. WERE CONFIRMATORY TESTS PERFORMED THAT DETERMINED THE RESULTS WERE IN ERROR? PANEL RESULT (DIRECT EXTERNAL PERFORMANCE EVALUATION - EEDD) LSP. RESULTS WITH INCONSISTENT GRAPHS WERE REPEATED AND WERE NEGATIVE IF NOT, HOW WERE THE ERRONEOUS RESULTS DETERMINED? NOT APPLICABLE WERE ERRONEOUS RESULTS REPORTED TO PHYSICIANS / PATIENTS? IF YES, WERE THERE ANY ADVERSE IMPACTS FOR PATIENTS? YES EXK PN KIT AND BATCH: 44500301 SARS-COV-2 REAGENTS FOR THE BD MAX SYSTEM LOT 1026980 LOT 1019554 PCR CARTRIDGES. MEDIA TYPE / BRAND: IMPROVIRAL NAT 3ML + HISOPO 8020111-500 IS THERE AN INACTIVATION STEP (PROVIDE PROTOCOL)? IRON INACTIVATION BY HEAT AT 55 ° C FOR 30 MINUTES TYPE OF SAMPLE? VOLUME? VISCOUS? NASOPHARYNGEAL SWAB AND EXCEPTIONALLY TRACHEAL SECRETIONS. VOLUME 750 UL UDP CONFIGURATION FOR SAMPLE VOLUME USED FOR EXTRACTION: 600 UL CONFIRMATION TESTS PERFORMED? (DESCRIBE THE TEST AND RESULTS) CONFIRMATION IS ALWAYS DONE WITH THE SAME BD MAX PLATFORM. CONFIRMATION PROCESS IS THE SAME AS ASSEMBLY, FROM THE PRETREATMENT OF THE SAMPLE, RESOLUTION OF THE PROBLEM IS OBSERVED BY REPEATING THE PROCESSING. DID BUBBLES APPEAR IN THE CARTRIDGES? NO DO THE REAGENT STRIP ADD-ONS APPEAR TO BE PROPERLY REHYDRATED? YES, REAGENTS IN NORMAL MACROSCOPIC STATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM 4 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING REPEATED BY BD MAN AND SEEGENE AND BOTH WERE NEGATIVE. THE RESULTS WERE REPORTED TO PHYSICIANS. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVIDENCE OF NON-CONCORDANT RESULTS IN SAMPLES FROM THE (B)(6) EVALUATIVE PANEL FOR THE BD MAX SARS COV-2 TEST THAT WERE REPORTED WITH A POSITIVE RESULT AND CORRESPONDED TO NEGATIVE SAMPLES. CUSTOMER ALSO REPORTED AN INCREASED NUMBER OF TESTS WITH ATYPICAL CURVES, IN WHICH ONLY 1 GENE IS AMPLIFIED AND THE TEAM INTERPRETS "POSITIVE". WITHIN THIS GROUP OF SAMPLES, THE LSPD EVALUATIVE PANEL AND SOME PATIENT SAMPLES HAVE BEEN REPORTED. SAMPLE 2105200244 GAVE THE FALSE POSITIVE PATTERN, IT WAS REPEATED BY BD MAX AND SEEGENE AND BY BOTH PLATFORMS IT WAS CONFIRMED NEGATIVE. A REVISION OF THE REAGENT LOT NUMBER WAS CARRIED OUT AND IT WAS EVIDENCED THAT WITH LOT # 1026980, THERE WAS A DOUBLE INCREASE IN REPETITION THAN THAT OBSERVED WITH LOTS 1026935 AND 1012622. WERE CONFIRMATORY TESTS PERFORMED THAT DETERMINED THE RESULTS WERE IN ERROR? PANEL RESULT (DIRECT EXTERNAL PERFORMANCE EVALUATION - EEDD) LSP. RESULTS WITH INCONSISTENT GRAPHS WERE REPEATED AND WERE NEGATIVE. IF NOT, HOW WERE THE ERRONEOUS RESULTS DETERMINED? NOT APPLICABLE. WERE ERRONEOUS RESULTS REPORTED TO PHYSICIANS / PATIENTS? IF YES, WERE THERE ANY ADVERSE IMPACTS FOR PATIENTS? YES. EXK PN KIT AND BATCH: 44500301 SARS-COV-2 REAGENTS FOR THE BD MAX SYSTEM LOT 1026980 LOT 1019554 PCR CARTRIDGES. MEDIA TYPE / BRAND: IMPROVIRAL NAT 3ML + HISOPO 8020111-500. IS THERE AN INACTIVATION STEP (PROVIDE PROTOCOL)? IRON INACTIVATION BY HEAT AT 55 ° C FOR 30 MINUTES. TYPE OF SAMPLE? VOLUME? VISCOUS? NASOPHARYNGEAL SWAB AND EXCEPTIONALLY TRACHEAL SECRETIONS. VOLUME 750 UL. UDP CONFIGURATION FOR SAMPLE VOLUME USED FOR EXTRACTION: 600 UL. CONFIRMATION TESTS PERFORMED? (DESCRIBE THE TEST AND RESULTS) CONFIRMATION IS ALWAYS DONE WITH THE SAME BD MAX PLATFORM. CONFIRMATION PROCESS IS THE SAME AS ASSEMBLY, FROM THE PRETREATMENT OF THE SAMPLE, RESOLUTION OF THE PROBLEM IS OBSERVED BY REPEATING THE PROCESSING. DID BUBBLES APPEAR IN THE CARTRIDGES? NO. DO THE REAGENT STRIP ADD-ONS APPEAR TO BE PROPERLY REHYDRATED? YES, REAGENTS IN NORMAL MACROSCOPIC STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921075 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1026980

    Patients

    Seq Age Sex Outcome Treatment
    1