BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    MDR report key: 11008141 · Received December 15, 2020

    Report

    Report Number
    1119779-2020-01211
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 25, 2020
    Report Date
    February 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-388 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 AND DATA ANALYSIS HAS REVEALED THAT THE KIT BIOGX SARS-COV-2 OSR WAS TESTED ALONG WITH THE EXTRACTION KIT BD MAX EXK TNA-3 LOT 0231382. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 LOT 0231382 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT BIOGX SARS-COV-2 OSR LOT K20-388 SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. CUSTOMER REPORTED FALSE POSITIVE RESULTS ON 2 PATIENT SAMPLES WITH BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM ASSAY BUT BOTH SAMPLES GAVE A NEGATIVE RESULT WHEN TESTED WITH ANOTHER ASSAY. CUSTOMER PROVIDED ONE RUN (#359) FROM THE DATABASE INSTRUMENT CT1769 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. RUN #359 CONTAINS THREE POSITIVES RESULTS SAMPLES. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. ANALYSIS OF ONE OF THREE POSITIVE RESULTS SHOWS A PCR CURVE CONSISTENT WITH A HIGH VIRAL LOAD WHILE THE TWO OTHERS SHOW A WEAK AMPLIFICATION, SUGGESTING THAT THEY PROBABLY CORRESPOND TO THE TWO DISCREPANT RESULTS, BUT NO INFORMATION WAS PROVIDED TO CONFIRM IT. ALL PCR CURVES FROM THE THREE POSITIVE RESULTS SHOW SIGMOIDAL CURVES WITH A HIGH ENDPOINT VALUE (MORE THAN 1000), SUGGESTING TRUE AMPLIFICATIONS. IF THE TWO DISCREPANT SAMPLES ARE ASSOCIATED TO THE TWO SAMPLES WITH A WEAK CT, THE POTENTIAL ROOT CAUSE COULD BE LOW POSITIVE SAMPLES. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOT K20-388. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. THE SAMPLES WERE RECOLLECTED AND REPEATED USING AN UNSPECIFIED TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT OR ANY 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 FALSE POSITIVE RESULTS WERE OBTAINED. THE SAMPLES WERE RECOLLECTED AND REPEATED USING AN UNSPECIFIED TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT OR ANY REPORT OF PATIENT IMPACT. EUA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478938 BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K20-388

    Patients

    Seq Age Sex Outcome Treatment
    1