BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10197677 · Received June 25, 2020

    Report

    Report Number
    1119779-2020-00181
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    May 25, 2020
    Report Date
    September 4, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    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 · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: MEDICAL DEVICE LOT #: 0100380. MEDICAL DEVICE EXPIRATION DATE: 2020-10-10. DEVICE MANUFACTURE DATE: 2020-04-09. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR UNRESOLVED RESULT WHEN USING THE KIT BD MAX SARS-COV-2 REAGENTS (REF 445003) ASSAY KIT LOT 0100380 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF THE CUSTOMER DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE COMPLAINT WAS MENTIONING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 0120611, BUT THIS KIT LOT DOES NOT EXIST. ANALYSIS OF THE CUSTOMER DATA REVEALED THE LOT USED WAS LOT #0100380. CONSEQUENTLY THE INVESTIGATION WAS PERFORMED ON THIS LOT. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE QC RESULTS WERE COMPLIANT. ACCORDING TO THE COMPLAINT TEXT, THE CUSTOMER COMPLAINED OF A HIGH RATE OF POSITIVE RESULTS PRESENTING LOW LEVELS OF FLUORESCENCE AND HIGH CT VALUES FOR THE N1 TARGET. FOR THE INVESTIGATION, TWO RUN FILES WERE PROVIDED (RUNS 2659 AND 2664). UDP SETTINGS WERE VERIFIED THROUGH THE CSV FILES AND ONE ERROR WAS NOTED. THE NEUTRALISATION VOLUME WAS SET TO 12.65L INSTEAD OF 12.5L. MOREOVER, THERE WAS NO INDICATION THAT THE CUSTOMER HAD SET THE ¿CALL CT AT THRESHOLD CROSSING WITH SECONDARY QC THRESHOLD¿, ALTHOUGH IT IS SPECIFIED IN THE PACKAGE INSERT. NO N1 POSITIVE/N2 NEGATIVE WAS FOUND, DESPITE THE INFORMATION WRITTEN IN THE COMPLAINT TEXT HOWEVER ONE SAMPLE IN EACH RUN PRESENTING A N1 NEGATIVE/N2 POSITIVE RESULT WAS FOUND. THE FIRST SAMPLE WAS IN LANE A04 OF RUN 2659 AND THE SECOND IN LANE A09 OF RUN 2664. SAMPLE A04 IN RUN 2659 APPEARS TO BE A TRUE LATE AMPLIFICATION OF THE N2 TARGET. HOWEVER WHEN THE RAW SIGNAL WAS EXAMINED, A GLITCH IN ALL CHANNELS WAS FOUND. THIS GLITCH COULD INDICATE THE PRESENCE OF A BUBBLE IN THE PCR CARTRIDGE WELL. THE 175L TIPS CONTAINED IN THE ASSAY STRIP COULD HAVE BE RESPONSIBLE FOR THE PRESENCE OF THIS BUBBLE. IT IS UNCLEAR IF THIS RESULT WAS A FALSE RESULT. BASED ON THE CURVES ANALYSIS, THE SAMPLE SEEMS TO BE A TRUE LATE POSITIVE. HOWEVER, THE SUSPECTED BUBBLE COULD ALSO HAVE CAUSED A FALSE N2 RESULT FOR THIS SAMPLE. THIS COULD NOT BE CONFIRMED. AS FOR SAMPLE A09 IN RUN 2664, IT WAS FOUND THAT THE FLUORESCENCE SIGNAL WAS HIGHER THAN THE OTHER SAMPLES IN THE SAME DECK. IMPROPER RECONSTITUTION OF THE MASTERMIX PELLET OR UNEXPECTED INSTRUMENT FAILURE COULD EXPLAIN THIS FALSE RESULT. MOREOVER, THERE WAS NO REAL AMPLIFICATION OF THIS TARGET. HOWEVER, THERE IS NO DOUBT ABOUT THE BD SARS-COV-2 REAGENT LOT SINCE A POSITIVE SAMPLE WAS ALSO TESTED IN THIS RUN (A07) AND GAVE EXPECTED N1/N2 AMPLIFICATION CURVES. THE ISSUE APPEARS TO BE LINKED TO THE HIGH FLUORESCENCE BACKGROUND IN THIS SAMPLE. BD HAS RECEIVED SEVERAL CUSTOMER COMPLAINTS FOR HIGH BACKGROUND NOISE WHEN USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM. THE ROOT CAUSE FOR THE FALSE POSITIVE RESULTS WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. THERE IS A COMPLAINT TREND FOR NON-REPORTABLE RESULTS (UNR & IND) ASSOCIATED TO THE 175UL TIPS, AND A CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED (PR# (B)(4)) TO INVESTIGATE THE 175 L TIPS CONTRIBUTION. IN ADDITION TO THAT A CORRECTIVE AND PREVENTIVE ACTION IS ALREADY INITIATED (CAPA PR# (B)(4)) TO INVESTIGATE THE ROOT CAUSE OF THE HIGH BACKGROUND FLUORESCENCE VALUES AND SOME MITIGATION ACTIONS ARE ALREADY IN PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657578 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. 0100380

    Patients

    Seq Age Sex Outcome Treatment
    1 Other