BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    MDR report key: 10083919 · Received May 22, 2020

    Report

    Report Number
    1119779-2020-00115
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    May 18, 2020
    Report Date
    July 23, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-116 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BIOGX. REVIEW OF THE MANUFACTURING RECORDS DID NOT INDICATE ANY ABNORMALITIES. RUN 4294 SAMPLE A5 WAS ANALYZED BY BIOGX. THOUGH LATE AND LOWER IN OVERALL END FLUORESCENCE, SIGNAL WAS INDICATIVE OF DETECTION OF N1 AND N2 RNA AT A LOW LEVEL (>35 CT) BEYOND WHERE THE 95% LOD IS EXPECTED. REPEAT TESTING OF THE SAME SAMPLE ONE DAY LATER SHOWS FAILURE TO AMPLIFY AND DETECT N1 OR N2 (BOTH RP TARGETS AMPLIFIED NORMALLY). FAILURE TO DETECT UPON REPEAT BEYOND THE 95% LOD IS NOT AN UNEXPECTED EVENT DUE TO SAMPLING VARIATION AND POTENTIAL TARGET DEGRADATION FROM THE ADDITIONAL TIME BETWEEN COLLECTION, FIRST RESULT, AND SECOND TESTING. NO ADDITIONAL INFORMATION IS PROVIDED BY CUSTOMER AS TO WHICH LUMINEX ASSAY IS BEING USED AS A COMPARATOR, NOR THE RESULTS OF THE OTHER GENE TARGETS WITHIN THE LUMINEX ASSAY. AS SUCH, BIOGX WAS UNABLE TO FULLY ADDRESS THE OBSERVED VARIATION. IT IS OF NOTE, THAT THE COMPARATOR ASSAY IS REPORTED AS HAVING A 95% LOD OF 3.33E+02 GCE/ML (GENOMIC COPY EQUIVALENTS) WHILE THE BD BIOGX SARS-COV-2 ASSAY HAS A 40 GE/ML 95% LOD. RETAIN MATERIAL WAS NOT TESTED BY BIOGX AS ISSUE CORRELATES WITH A SINGLE SAMPLE COLLECTED AT CUSTOMER LOCATION. POSITIVES SEEN IN INITIAL RESULTS AND NEGATIVES IN SECOND TESTING ARE NOT UNEXPECTED DUE TO THE LATE POSITIVES OBSERVED IN THE INITIAL SAMPLE. N2 AND N1 WERE INITIALLY DETECTED BEYOND THE 95% LOD. REPEAT SAMPLING RESULTED IN FAILURE TO DETECT N1 OR N2, AND IS NOT AN UNEXPECTED RESULT GIVEN THE AMOUNT OF TARGET PRESENT BASED ON THE 35.8 AND 40.3 CT VALUES. AS THIS COMPLAINT DOES NOT APPEAR TO BE RELATED TO PERFORMANCE CHARACTERISTICS OF THE ASSAY, TESTING OF RETAIN MATERIALS HAS NOT BEEN INITIATED IN ORDER TO UNDERSTAND ASSAY PERFORMANCE FOR TARGETS BEYOND THE 95% LOD. THE ROOT CAUSE WAS NOT FOUND BUT SAMPLES NEAR THE LIMIT OF DETECTION OF THE ASSAY (BOTH LUMINEX AND BIOGX) ARE SUSPECTED. THERE IS NO COMPLAINT TREND RELATED TO DISCREPANT RESULTS WITH THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM LOT K20-116. BIOGX DID NOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BIOGX PRODUCT MANUFACTURER DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BIOGX SARS-COV-2 OSR ASSAY FOR THE BD MAX SYSTEM THE CUSTOMER RECEIVED ERRONEOUS RESULTS. THE SAMPLE INITIALLY TESTED AS POSITIVE. A CONFIRMATORY TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE. CUSTOMER REPORTED THE FINAL RESULT AS NEGATIVE AND THERE WAS NO CHANGE IN COURSE OF TREATMENT.

    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 THAT WHILE USING THE BIOGX SARS-COV-2 OSR ASSAY FOR THE BD MAX SYSTEM THE CUSTOMER RECEIVED ERRONEOUS RESULTS. THE SAMPLE INITIALLY TESTED AS POSITIVE. A CONFIRMATORY TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE. CUSTOMER REPORTED THE FINAL RESULT AS NEGATIVE AND THERE WAS NO CHANGE IN COURSE OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547980 BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other