BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12456877 · Received September 10, 2021

    Report

    Report Number
    1119779-2021-01496
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 16, 2021
    Report Date
    October 28, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY 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 COMPLAINED ABOUT A SPECIMEN THAT WAS DETECTED N1 POSITIVE WITH A CT VALUE OF 41.8 CYCLES. THE CUSTOMER REPEATED THE SAMPLE, AND THE RESULT WAS NEGATIVE. CUSTOMER PROVIDED TWO RUNS #644 AND #657 FROM INSTRUMENT CT2128 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. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ACROSS THE TWO RUNS PROVIDED. SAMPLE TESTED ON LANE A01 OF RUN 644 IS THE ONE SUSPECTED TO BE FALSE POSITIVE BY THE CUSTOMER. THE CUSTOMER WANTED TO KNOW WHY THE SPECIMEN IN LANE A01 WAS CALLED N1 POSITIVE WITH A CT VALUE OF 41.8, SINCE THE CUSTOMER THOUGHT THAT THE CUT-OFF IS 40.0. THE CUT-OFF FOR N1 TARGET IS IN FACT 42.0. THE SAMPLE WAS REPEATED IN RUN 657 (LANE B02) AND THE RESULT WAS N1 NEGATIVE. THE MANUAL PCR CURVE ADJUDICATION ANALYSIS REVEALED LATE AND LOW, BUT TRUE, N1 POSITIVE RESULT FOR THE INITIAL TESTING (LANE A01 RUN 644). SUCH DISCREPANT RESULT UPON REPEAT COULD BE OBTAINED WITH LOW POSITIVE SAMPLE. LOW POSITIVE SAMPLE 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. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMEN AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION ARE THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER POSITIVE N1 RESULT. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER POSITIVE N1 RESULT. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. NO PRODUCT 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. NOTE THAT 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). H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT FALSE POSITIVE RESULT IN BD SARS COV-2 ASSAY N1 TARGET. "

    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 A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT FALSE POSITIVE RESULT IN BD SARS COV-2 ASSAY N1 TARGET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351528 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