BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10942284 · Received December 3, 2020

    Report

    Report Number
    1119779-2020-01130
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 13, 2020
    Report Date
    February 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-485 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 DATA ANALYSIS WAS REVEALED THAT THE KIT BIOGX SARS-COV-2 OSR WAS TESTED ALONG WITH THE EXTRACTION KIT BD MAX EXK TNA-3 LOT 0248752. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 LOT 0248752 INDICATED THAT THE LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT BIOGX SARS-COV-2 OSR LOT K20-485 SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. CUSTOMER REPORTED HIGH RATE OF POSITIVE RESULTS AND REQUESTED EVALUATION OF RUN #4748. CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT0490 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 #4748 CONTAINS 20 SAMPLES INCLUDING FIVE N1 & N2 POSITIVES (A9, A2, A3, B2 & B8) AND 2 OTHER N2 POSITIVES ONLY (A4 ET B7). MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS SAMPLES. 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 THE PCR CURVE FOR RUN #4748, LANE A9 SHOWS A TRUE AMPLIFICATION WITH AN EARLY CT AND A HIGH ENDPOINT FOR TARGETS N1 AND N2. THIS SAMPLE LOOKS LIKE A TRUE AND STRONG POSITIVE RESULT. ANALYSIS OF PCR CURVE FOR RUN#4748, LANES A4 & B7, SHOW A TRUE BUT LATE AMPLIFICATION FOR TARGET N1, WITHOUT ANOMALY. SINCE SOME VERY STRONG SARS COV-2 N1/N2 POSITIVE RESULTS WERE OBSERVED ON THE SAME RUN, CONTAMINATION DURING SAMPLE AND/OR MATERIAL HANDLING AT CUSTOMER SITE COULD EXPLAIN THESES LATE POSITIVES RESULTS OBSERVED. LOW POSITIVE SAMPLES CAN ALSO 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. BD IS NOT ABLE TO CONFIRM THESE HYPOTHESES. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOT K20-485. THE ROOT CAUSE WAS NOT IDENTIFIED BUT CONTAMINATION BY CUSTOMERS AND/OR TRUE POSITIVE SAMPLE AT THE LIMIT OF DETECTION ARE SUSPECTED. 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 THERE WERE A HIGH RATE OF FALSE POSITIVES OBTAINED. WHEN REPEATED THE RESULTS WERE OFTEN NEGATIVE. NO OTHER CONFIRMATION TESTING WAS REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4).

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). MEDICAL DEVICE LOT #: 0248752 WAS REPORTED, HOWEVER, THIS IS THE LOT# FOR THE KIT BD MAX EXK TNA-3 NOT THE LOT # FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 THERE WERE A HIGH RATE OF FALSE POSITIVES OBTAINED. WHEN REPEATED THE RESULTS WERE OFTEN NEGATIVE. NO OTHER CONFIRMATION TESTING WAS REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406558 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1