BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11912743 · Received June 1, 2021

    Report

    Report Number
    1119779-2021-00916
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    April 30, 2021
    Report Date
    July 27, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOTS 1012622 AND 1012623 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 LOTS 1012622 AND 1012623 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED AN INCREASE OF FALSE POSITIVE RESULTS, USUALLY POSITIVE ONLY FOR THE N1 OR N2 TARGET, IN THE LAST MONTH. THE SAMPLES ARE NEGATIVE UPON REPEAT. CUSTOMER PROVIDED DATABASE FROM INSTRUMENT CT1584 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. ANALYSIS OF THE DATABASE IN TIME AS WELL AS BY KIT LOT, FOR THE PERIOD BETWEEN OCTOBER 2020 AND APRIL 2021, SHOWS THAT, EXCEPT FOR A PEAK OF POSITIVE RESULTS BETWEEN NOVEMBER 2020 AND FEBRUARY 2021, WHICH COULD BE DUE TO SOME OUTBREAK, FLUCTUATIONS IN THE RATE OF POSITIVE RESULTS WERE OBSERVED, WITH NO INCREASE IN THE LAST MONTH. THIS IS ALSO TRUE FOR SAMPLES WITH ONLY N1 OR N2 TARGET POSITIVE RESULTS. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL THE SUSPECTED FALSE POSITIVE N1 OR N2 SAMPLES FROM RUNS NAMED IN COMPLAINT (RUN #725 AND #732). 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 REVEALED LATE AND LOW BUT TRUE AMPLIFICATION FOR TARGETS N1 OR N2 WITHOUT ANOMALY, INDICATIVE OF TRUE POSITIVES RESULTS. 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. NO REPEAT TEST WAS FOUND FOR THESE SAMPLES IN THE DATABASE. CUSTOMER MENTIONED HAVING PERFORMED EXTENSIVE CLEANING TO RULE OUT CONTAMINATION. HOWEVER, NO SPECIFIC INFORMATION WAS PROVIDED ABOUT THE EXTENSIVE CLEANING CONDUCTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX SARS-COV-2 REAGENTS LOTS 1012622 AND 1012623. 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 THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. 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 APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED AND THE RESULT WAS 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: "THE CUSTOMER NOTICED AN ACCUMULATION OF FALSE POSITIVE RESULTS FOR THE BD SARSCOV REAGENTS IN THE LAST MONTH, WHERE USUALLY ONLY ONE GENE (EITHER N1 OR N2) WAS POSITIVE. USUALLY THE CT VALUE WAS HIGH AND THE FLUORESCENCE LEVEL LOW. UPON REPEAT OF THE SAMPLE THE RESULTS ARE NEGATIVE. "

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1012622. MEDICAL DEVICE EXPIRATION DATE: 2021-07-30. DEVICE MANUFACTURE DATE: 2021-01-12. MEDICAL DEVICE LOT #: 1012623. MEDICAL DEVICE EXPIRATION DATE: 2021-07-23. DEVICE MANUFACTURE DATE: 2021-01-12. 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. A REPEAT TEST WAS PERFORMED AND THE RESULT WAS 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: "THE CUSTOMER NOTICED AN ACCUMULATION OF FALSE POSITIVE RESULTS FOR THE BD SARSCOV REAGENTS IN THE LAST MONTH, WHERE USUALLY ONLY ONE GENE (EITHER N1 OR N2) WAS POSITIVE. USUALLY THE CT VALUE WAS HIGH AND THE FLUORESCENCE LEVEL LOW. UPON REPEAT OF THE SAMPLE THE RESULTS ARE NEGATIVE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811248 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