BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11645109 · Received April 9, 2021

    Report

    Report Number
    3006948883-2021-00373
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    June 10, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 1026931 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 1026931 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT N1 POSITIVE SAMPLES WITH BD MAX SARS-COV-2 REAGENTS KIT WHICH TESTED NEGATIVE WITH ANOTHER ASSAY (GENEXPERT, CEPHEID). CUSTOMER PROVIDED FOUR RUNS FILES (#874, 884, 886 AND 890) FROM INSTRUMENT CT1742 FOR INVESTIGATION. 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. THE RUNS 874, 884, 886 AND 890 EACH CONTAINS 5 SAMPLES TESTED WITH THE BD SARS-COV-2 REAGENTS. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED FOR ALL SAMPLES WITH N1 POSITIVE RESULT. 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. ANALYSIS OF PCR CURVES LOOK LIKE LATE AND LOW BUT TRUE AMPLIFICATION, INDICATIVE OF TRUE N1 POSITIVE RESULTS. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. THE CUSTOMER ALSO QUESTIONED THE FACT THAT THEY OBSERVED HIGHER N1 POSITIVE RESULTS RATES, COMPARED TO N2 POSITIVES. THEIR POSITIVITY REPORT WAS REVIEWED AND SHOWED COMPARABLE N1 POSITIVE RESULTS RATES VS N2 POSITIVE RESULTS. ACCORDING TO THE BD MAX SARS-COV-2 REAGENTS INSTRUCTION FOR USE, A POSITIVE SARS-COV-2 RESULT IS OBTAINED IF N1 AND/OR N2 TARGETS ARE POSITIVE. AS FOR THE DISCREPANCIES OBTAINED BETWEEN THE BD SARS-COV-2 REAGENTS KIT AND THE VERIFICATION METHOD (GENEXPERT, CEPHEID), IT MUST BE NOTED THAT THIS ASSAYS ONLY DETECTS THE N2 AND E GENE TARGETS AND DOES NOT DETECT THE N1 TARGET. THEREFORE, WITH THIS ASSAY, THE CUSTOMER CANNOT CONFIRM THE N1 POSITIVE RESULTS OBTAINED WITH THE BD SARS-COV-2 REAGENTS KIT. LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. BASED ON THE DATA PROVIDED, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. THE ANALYSIS STRONGLY SUGGESTS TRUE LOW POSITIVE RESULTS. NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX SARS-COV-2 REAGENTS LOT 1026931. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING THE GENEXPERT AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " SHORT DESCRIPTION FALSE POSITIVE TARGET N1 WHERE DID THE INCIDENT OCCUR DURING USE DETAILED INCIDENT DESCRIPTION FALSE POSITIVE ON N1 TARGET. MANY CURVES COME OUT POSITIVE ON N1 WHILE ON GENEXPERT THE SAME SAMPLES COME OUT NEGATIVE. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? NO".

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING THE GENEXPERT AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " SHORT DESCRIPTION FALSE POSITIVE TARGET N1. WHERE DID THE INCIDENT OCCUR DURING USE DETAILED INCIDENT DESCRIPTION FALSE POSITIVE ON N1 TARGET. MANY CURVES COME OUT POSITIVE ON N1 WHILE ON GENEXPERT THE SAME SAMPLES COME OUT NEGATIVE. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543216 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1026931

    Patients

    Seq Age Sex Outcome Treatment
    1