BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    MDR report key: 10083920 · Received May 22, 2020

    Report

    Report Number
    1119779-2020-00114
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    May 20, 2020
    Report Date
    July 17, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION: INVESTIGATION INV-20-PLC-167 WAS COMPLETED ON 2020-06-19. IT CONCERNED ONE DISCREPANT RESULT OBTAINED WITH BD BIOGX SARS COV-2 REAGENT FOR BD MAX¿ KIT LOT K20-048, USED IN COMBINATION WITH THE BD MAX¿ EXK¿ TNA-3 KIT LOT 0084465. IT CONSISTED IN VERIFICATION OF THE COMPLAINTS HISTORY, AS WELL AS VERIFICATION OF THE MANUFACTURING OF BD MAX¿ EXK¿ TNA-3 KIT LOT 0084465 AND CUSTOMER DATA. THE COMPLAINTS HISTORY SHOWED NO OTHER COMPLAINT ON BD MAX¿ EXK¿ TNA-3 KIT LOT 0084465. IN THE LAST TWELVE MONTHS, 11 OTHER COMPLAINTS WERE RECEIVED, CONCERNING A SIMILAR ISSUE (DISCREPANT RESULTS), WITH THE BD MAX¿ EXK¿ TNA-3 AND THE BD BIOGX SARS-COV-ASSAYS, MOST LIKELY CAUSED BY SAMPLES AT THE LIMIT OF DETECTION OF THE PARTNER¿S KIT OR THE ALTERNATIVE METHOD. MANUFACTURING RECORDS OF THE OF THE BD BIOGX SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT K20-048 IS NOT AVAILABLE. MANUFACTURING RECORDS OF THE OF THE BD MAX¿ EXK¿ TNA-3 KIT LOT 0084465 DID NOT SHOW FALSE POSITIVE RESULT AND WAS WITHIN THE TRENDS OF THE QC RESULTS FOR THE LAST 12 MONTHS. REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-048 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS, AND TNA-3 LOT 0084465 WAS CONFORMING AND PASSED THE QC SPECIFICATIONS FOR RELEASE AND USE. THE SYMPTOMATIC PATIENT WAS TESTED FOUR TIMES AND OBTAINED A N2 POSITIVE RESULT ONCE. ONLY THE RUN CONTAINING THE N2 POSITIVE RESULT IS AVAILABLE FOR ANALYSIS. AMPLIFICATION CURVE FROM THE DISCREPANT RESULT SHOWS A TRUE BUT LATE AMPLIFICATION OF THE N2 TARGET. THE INTERNAL CONTROL FROM THE SAME WELL (BOT POSITION) FOR THIS SAMPLE SHOWED A GOOD AMPLIFICATION (NO INHIBITION SUSPECTED). SINCE THE AMPLIFICATION IS LATE AND THE SAMPLE OBTAINED A NEGATIVE RESULT AT THREE OCCASIONS, THE MOST PROBABLE CAUSE OF THE DISCREPANT IS A CONTAMINATION. HOWEVER, A POSITIVE SAMPLE AT THE LIMIT OF DETECTION OF THE BD BIOGX SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM CANNOT BE EXCLUDED. THEREFORE, RETAIN MATERIAL WAS NOT TESTED. THE RESULTS SHOWED NORMAL BUT LATE CURVES, SUGGESTING TRUE AMPLIFICATION AND BD BIOGX SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM WAS NOT AVAILABLE FOR TESTING. MOREOVER, BD MAX¿ EXK¿ TNA-3 ASSAY IS AN OPEN SYSTEM ASSAY, WITHOUT PRIMERS AND PROBES TO VERIFY POSITIVE TARGETS IN OUR FACILITY. WITHOUT THIS MASTER MIX, RETAIN MATERIAL TESTING WOULD NOT PROVIDE ADDITIONAL INFORMATION FOR THE CURRENT ISSUE AND WAS NOT PERFORMED. THE ROOT CAUSE WAS NOT FOUND BUT SAMPLES NEAR THE LIMIT OF DETECTION OF THE ASSAY OR SAMPLE CONTAMINATION ARE SUSPECTED. THERE IS NO COMPLAINT TREND RELATED TO DISCREPANT RESULTS WITH THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM LOT K20-048. BIOGX AND BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BIOGX OR BD DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN (CAPA). UPDATE RISK MANAGEMENT FILE: NO UPDATE PERFORMED BY BD SINCE BD DOES NOT OWN THE PRODUCT RISK MANAGEMENT FILE SINCE THE PRODUCT IS MANUFACTURED BY A PARTNER (BIOGX). THIS PRODUCT IS AVAILABLE ON THE MARKET WITH THE FDA EMERGENCY USE AUTHORIZATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BIOGX SARS-COV-2 OSR ASSAY FOR THE BD MAX SYSTEM REPORTED DISCREPANT RESULTS. THE CUSTOMER RAN A COVID SAMPLE ON A SYMPTOMATIC PATIENT, AND THE RESULT WAS NEGATIVE. UPON REPEAT THE SAMPLE WAS POSITIVE. THE CUSTOMER REPEATED THE SAMPLE TWO MORE TIMES, AND EACH RESULT WAS NEGATIVE. THERE WAS NO CHANGE IN COURSE OF PATIENT TREATMENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 THAT THE BIOGX SARS-COV-2 OSR ASSAY FOR THE BD MAX SYSTEM REPORTED DISCREPANT RESULTS. THE CUSTOMER RAN A COVID SAMPLE ON A SYMPTOMATIC PATIENT, AND THE RESULT WAS NEGATIVE. UPON REPEAT THE SAMPLE WAS POSITIVE. THE CUSTOMER REPEATED THE SAMPLE TWO MORE TIMES, AND EACH RESULT WAS NEGATIVE. THERE WAS NO CHANGE IN COURSE OF PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547981 BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other