BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10652985 · Received October 8, 2020

    Report

    Report Number
    1119779-2020-00502
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 16, 2020
    Report Date
    November 30, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA #: EUA(B)(4) H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF (B)(4)) LOT K20-346 ALONG WITH THE KIT BD MAX EXK TNA 3 PRODUCT LOT 0182270 WAS PERFORMED BY BD. THE INVESTIGATION WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF THE CUSTOMER DATA, RETAIN MATERIAL TESTING AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-346 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA 3 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED POSITIVE RESULTS (8 SAMPLES) ON RUN #1872 BUT REPEATED NEGATIVE ON RUN #1875, BOTH RUNS WERE PROVIDED FOR ANALYSIS. ANALYSIS OF THE CURVE IN RUN #1872, POSITION A5, SHOW A HIGH LOAD SAMPLE WITH A CT SCORE AROUND 12 FOR BOTH TARGETS N1/N2. ALL OTHER POSITIVE SAMPLES IN THIS RUN OBTAINED A LATE CT SCORE AROUND 35 FOR ONE OR BOTH TARGETS. ALL CURVES PRESENT A TRUE AMPLIFICATION WITHOUT ANOMALY. SINCE AMPLIFICATIONS WERE LATE WITH A SIMILAR CT SCORE, AND ALL SAMPLES OBTAINED A NEGATIVE RESULT UPON REPEAT (EXCEPT SAMPLE WITH THE HIGH LOAD IN POSITION A5), THE MOST PROBABLE CAUSE OF THE DISCREPANT IS A CONTAMINATION THAT OCCURRED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE, POTENTIALLY CAUSED BY THE HIGH LOAD SAMPLE. THE RETAIN MATERIAL TESTING BY BIOGX SHOWS PERFORMANCES WITHIN SPECIFICATIONS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS COMPLAINTS FOR THE BIOGX SARS-COV-2 OSR LOT K20-346. 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 THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR 8 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE. THE INITIAL POSITIVE RESULT WAS DISCARDED, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: EUA(B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). EUA #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR 8 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE. THE INITIAL POSITIVE RESULT WAS DISCARDED, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118375 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K20-346

    Patients

    Seq Age Sex Outcome Treatment
    1 Other