BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    MDR report key: 12724056 · Received October 29, 2021

    Report

    Report Number
    1119779-2021-01735
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 1, 2021
    Report Date
    December 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT (REF 44500301) LOT 1120370 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM INDICATED THAT LOT 1120370 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED SEVERAL SAMPLES WITH POSITIVE RESULTS FOR THE N1 TARGET AND N2 TARGET NEGATIVE RESULTS, WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 1120370, THAT WERE NEGATIVE WHEN TESTED BY ANOTHER LABORATORY (ASSAY USED NOT SPECIFIED). CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT2184 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 FOR BD MAX¿ SYSTEM INSTRUCTION FOR USE. THE CUSTOMER MENTIONED SEVERAL SAMPLES WITH N1 POSITIVE/N2 NEGATIVE RESULTS THAT WERE NEGATIVE WHEN TESTED BY ANOTHER LABORATORY. MOREOVER, THE CUSTOMER PERFORMED SEVERAL ENVIRONMENTAL MONITORING WHICH REVEALED SOME POSITIVE RESULTS. SINCE NO SAMPLE IDENTIFICATION WAS PROVIDED, ALL THE POSITIVE RESULTS IN WHICH ONLY THE N1 TARGET WAS DETECTED WHILE USING LOT 1120370, WERE ANALYZED. AMONG THESE POSITIVE SAMPLES, FOUR CORRESPOND TO PATIENT SAMPLES. ONE WAS REPEATED AND GAVE THE SAME RESULTS UPON REPEAT (POSITIVE FOR THE N1 TARGET WITH SIMILAR CT AND FLUORESCENCE ENDPOINT RESULTS IN BOTH ORIGINAL AND REPEAT TESTS), SUGGESTING THAT THE SAMPLE IS A TRUE POSITIVE RESULT. THE OTHER SAMPLES CORRESPOND TO ENVIRONMENTAL MONITORING SAMPLES, AS WELL AS TWO BLANK SAMPLE BUFFER TUBES. SOME OF THE ENVIRONMENTAL MONITORING SAMPLES WERE REPEATED AND REMAINED POSITIVE FOR THE N1 TARGET. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS OF ALL THE N1 POSITIVE SAMPLES. PCR CURVES ANALYSIS REVEALED LATE AND LOW, BUT TRUE AMPLIFICATIONS FOR N1 TARGET, WITHOUT ANOMALY, INDICATIVE OF TRUE POSITIVE 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. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. BASED ON THE INVESTIGATION RESULTS, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM LOT 1120370. THE ROOT CAUSE WAS NOT IDENTIFIED. POSITIVES SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY OR A THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE CAN EXPLAIN THE CUSTOMER DISCREPANT SAMPLES. 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. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED 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: " CUSTOMER REPORTING SEVERAL ALLEGED FALSE POSITIVE RESULTS ON THE BD COV-2 ASSAY, CATALOG# 44500301, LOT# 1120370."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED 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: " CUSTOMER REPORTING SEVERAL ALLEGED FALSE POSITIVE RESULTS ON THE BD COV-2 ASSAY, CATALOG# 44500301, LOT# 1120370"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621111 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1120370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown