BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11820608 · Received May 13, 2021

    Report

    Report Number
    1119779-2021-00825
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOTS 1026938 AND 1033566 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 BD MAX SARS-COV-2 REAGENTS INDICATED THAT THE LOTS 1026938 AND 1033566 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT N1 POSITIVE SAMPLES WITH BD SARS-COV-2 REAGENTS KIT LOT 1026938 WHICH TESTED NEGATIVE WITH ANOTHER ASSAY (GENEXPERT, CEPHEID). ALTHOUGH THE COMPLAINT WAS OPENED FOR LOT 1026938, ANALYSIS OF THE RUNS PROVIDED ALSO SHOWED THE USE OF LOT 1033566. BOTH LOTS WERE THUS INVESTIGATED IN THIS REPORT. CUSTOMER PROVIDED TWO RUN FILES 332 AND 333, PERFORMED ON INSTRUMENT CT2158 FOR INVESTIGATION. THE COMPLAINT TEXT MENTIONED DISCREPANT RESULTS OBTAINED IN RUNS 323 AND 333. HOWEVER, RUN 332 WAS PROVIDED INSTEAD OF RUN 323. NONETHELESS, THE SAMPLE ID CORRESPOND TO THE ONES DESCRIBED IN THE COMPLAINT TEXT AND THIS RUN WAS THUS PRESUMED TO BE THE CORRECT ONE REFERRED TO BY THE CUSTOMER. 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 SAMPLES IDENTIFIED BY CUSTOMER: RUN #332, POSITION A6 AND RUN #333, POSITION A9. 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. PCR CURVES FOR BOTH SAMPLES SHOW LATE AND LOW BUT TRUE AMPLIFICATION FOR N1 TARGET. BOTH SAMPLES LOOK LIKE TRUE POSITIVES SAMPLES AT THE LIMIT OF DETECTION (LOD) OF THE ASSAY. 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. IT MUST BE NOTED THAT THE GENEXPERT ASSAY ONLY DETECTS N2 AND E GENE TARGETS AND DOES NOT DETECT THE N1 TARGET. THEREFORE, THE CUSTOMER CANNOT CONFIRM THE N1 POSITIVE RESULTS OBTAINED WITH THE BD SARS-COV-2 REAGENTS KIT WITH THE GENEXPERT ASSAY. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. ACCORDING TO THE PACKAGE INSERT (P0255), A POSITIVE SARS-COV-2 RESULT IS OBTAINED IF N1 AND/OR N2 TARGETS ARE POSITIVE. BASED ON THE DATA PROVIDED, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS, BUT OVERALL, NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX SARS-COV-2 REAGENTS LOTS 1026938 AND 1033566. 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). H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR OR SARS-COV-2 WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM 2 A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING GENE XPERT AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2) RUN 323 - PATIENT ID-(B)(6) N1 POS CT 36.7 CONFIRMED NEG ON GENE XPERT SAME DAY

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR OR SARS-COV-2 WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM 2 A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING GENE XPERT AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2) RUN 323 - PATIENT ID - (B)(6). N1 POS. CT 36.7. CONFIRMED NEG ON GENE XPERT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713512 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1026938

    Patients

    Seq Age Sex Outcome Treatment
    1