BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    MDR report key: 10792949 · Received November 5, 2020

    Report

    Report Number
    1119779-2020-00912
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 14, 2020
    Report Date
    February 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-389 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX SINCE LOT K20-389 WAS TESTED ALONG WITH BD MAX EXK TNA-3 LOT 0189428. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-389 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 LOT 0189428 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED ONE DISCREPANT RESULT ON PATIENT SAMPLE. CUSTOMER PROVIDED TWO PDF REPORT OF RUN #675 & 677 FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BIOGX SARS COV-2 PACKAGE INSERT INSTRUCTION FOR USE. ONE SAMPLE WAS N2 POSITIVE IN RUN 675, BUT WAS NEGATIVE WHEN RETESTED IN RUN 677, USING A NEW SAMPLE PREPARATION. SINCE THE DATA PROVIDED CONSISTED IN PHOTOCOPIES OF THE CURVES, PRESENTED AS FAINTED BLACK AND WHITE PDF REPORTS, IT WAS NOT POSSIBLE TO ANALYZE AMPLIFICATION CURVES OF THE DISCREPANT SAMPLE. NONE OF THE SAMPLES COULD BE IDENTIFIED IN THE FILES. WITH THE DATA PROVIDED, BD WAS UNABLE TO CONFIRM THE CUSTOMER ISSUE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOT K20-389. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD & BIOGX PRODUCT MANUFACTURER DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. THE SAMPLE WAS REPEATED ON THE MAX, AND UPON REPEAT THE RESULT WAS NEGATIVE. THE SAMPLE WAS ALSO SENT FOR CONFIRMATORY TESTING USING A DIFFERENT TEST METHOD AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. THE SAMPLE WAS REPEATED ON THE MAX, AND UPON REPEAT THE RESULT WAS NEGATIVE. THE SAMPLE WAS ALSO SENT FOR CONFIRMATORY TESTING USING A DIFFERENT TEST METHOD, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261647 BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K20-389

    Patients

    Seq Age Sex Outcome Treatment
    1