BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    MDR report key: 10051653 · Received May 13, 2020

    Report

    Report Number
    1119779-2020-00100
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    May 7, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULT WITH THE BIOGX SARS-COV-2 OSR ASSAY (REF #(B)(4)) LOT K20-006 WAS PERFORMED BY BIOGX, PRODUCT MANUFACTURER. THE INVESTIGATION WAS PERFORMED BY REVIEW OF THE BATCH HISTORY RECORD AND REVIEW OF THE CUSTOMER DATA. REVIEW OF BATCH HISTORY RECORDS FOR AFFECTED LOTS DO NOT INDICATE PERFORMANCE ISSUES. CUSTOMER REPORT THAT OF 151 SAMPLES TESTED USING THIS LOT NUMBER, 10 SAMPLES TESTED POSITIVE FOR N1 ONLY WITH A CT VALUE RANGING FROM 36.4 ¿ 41.3. BIOGX ANALYSIS OF CUSTOMER DATA SHOWS SEVERAL N1 SAMPLES AS LATE POSITIVES HAVING CT VALUES >35. THE BD EUA IFU INDICATES A LIMIT OF DETECTION OF 40 GE/ML YIELDING AVERAGE CT VALUES OF 33.8 AND 33.7 FOR N1 AND N2, RESPECTIVELY. THE LATE POSITIVES THE CUSTOMER IS OBSERVING WOULD REQUIRE REPEATED PATIENT SAMPLING ON THE SAME INSTRUMENT. THE CUSTOMER USE OF AN UNKNOWN ALTERNATIVE PLATFORM CANNOT BE TAKEN INTO ACCOUNT WITHOUT ADDITIONAL IFU INFORMATION ABOUT THE PLATFORM. BIOGX INDICATES THAT FOR PATIENT COLLECTIONS CONTAINING VIRAL RNA LOADS BEYOND THE LOD, REPEATED PATIENT SAMPLING WOULD BE REQUIRED. END USERS MUST REFERENCE THE IFU AND UNDERSTAND LOD VALUES AND RELATIONSHIP TO VIRAL LOADS. THERE IS NO TREND FOR FALSE POSITIVE RESULT WITH THE BIOGX SARS-COV-2 OSR ASSAY LOT K20-006. BIOGX CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. THE ROOT CAUSE OF THE CUSTOMER ISSUE WAS NOT IDENTIFIED. BIOGX PRODUCT MANUFACTURER DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM ERRONEOUS RESULTS WERE REPORTED. THE CUSTOMER STATED THAT THIS LOT HAD A HIGHER LEVEL OF N1 POSITIVITY, AND 10 SAMPLES WERE REPORTED AS FALSE POSITIVE. ALL SAMPLES WERE REPEATED AND/OR CONFIRMED BY AN ALTERNATE METHOD AND WERE NEGATIVE. THE CUSTOMER IS UNAWARE OF ANY CHANGE IN COURSE OF TREATMENT DUE TO THE ERRONEOUS RESULTS.

    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 USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM ERRONEOUS RESULTS WERE REPORTED. THE CUSTOMER STATED THAT THIS LOT HAD A HIGHER LEVEL OF N1 POSITIVITY, AND 10 SAMPLES WERE REPORTED AS FALSE POSITIVE. ALL SAMPLES WERE REPEATED AND/OR CONFIRMED BY AN ALTERNATE METHOD AND WERE NEGATIVE. THE CUSTOMER IS UNAWARE OF ANY CHANGE IN COURSE OF TREATMENT DUE TO THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518252 BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other