BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10468381 · Received August 28, 2020

    Report

    Report Number
    1119779-2020-00301
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    August 7, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: K20-243. D.4. MEDICAL DEVICE EXPIRATION DATE: 12/20/2020. H.4. DEVICE MANUFACTURE DATE: 6/26/2020. H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOTS K20-243 WAS PERFORMED. THE INVESTIGATION WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF THE CUSTOMER DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCT BY BD AND BIOGX. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-243 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. CUSTOMER PROVIDED 2 RUNS AND REPORTED A FALSE POSITIVE N2 IN RUN #366 AND A NEGATIVE RESULT IN RUN #367. AMPLIFICATION CURVE ANALYSIS REVEALED A LATE BUT TRUE AMPLIFICATION OF THE N2 TARGET IN RUN 366, POSITION B5 BUT NO AMPLIFICATION OF THE N2 TARGET IN RUN 367, POSITION B3. ANALYSIS OF CURVE IN RUN #366 SHOWS THAT CT OF THE N2 AMPLIFICATION CURVE IS LATE, THE ENDPOINT IS HIGH, WITH A PCR CURVE SHAPE INDICATIVE OF TRUE AMPLIFICATION OF THE TARGET, AT A LOW LOAD, NEAR THE ASSAY LIMIT OF DETECTION (LOD). ANOTHER HYPOTHESIS IS CONTAMINATION DURING SAMPLES PREPARATION. THERE IS NO COMPLAINT TREND RELATED TO FALSE POSITIVE RESULTS WITH THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM LOT K20-243. THE ROOT CAUSE WAS NOT FOUND. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BIOGX OR BD DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN (CAPA).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE RESULTS WERE REPEATED, AND UPON REPEAT THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE RESULTS WERE REPEATED, AND UPON REPEAT THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933615 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-243

    Patients

    Seq Age Sex Outcome Treatment
    1 Other