BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10288884 · Received July 17, 2020

    Report

    Report Number
    1119779-2020-00238
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    July 1, 2020
    Report Date
    October 23, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: K20-180. D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2020. H.4. DEVICE MANUFACTURE DATE: 6/4/2020. H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WHEN USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-180 WAS PERFORMED BY THE REVIEW OF THE BATCH HISTORY RECORD, THE REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCT BY BD AND BIOGX SINCE LOT K20-180 WAS TESTED ALONG WITH BD MAX EXK TNA-3 LOT 0114415. THE REVIEW OF THE BATCH HISTORY RECORDS OF THE BIOGX SARS-COV-2 OSR INDICATED THAT K20-180 LOT SHOWS EXPECTED PERFORMANCE. CUSTOMER RUN # (B)(6) WAS ANALYZED. CUSTOMER REPORTS N1 FALSE POSITIVE RESULT ON THE BD MAX BUT NEGATIVE WITH OTHER PCR METHODS. ANALYSIS OF THE CURVE ON RUN (B)(6) SHOWS A GLITCH CAUSING AN INTERRUPTION IN BACKGROUND CORRECTION, GENERATING A STEADY INCREASE OF FLUORESCENCE IN THE CURVE, RESULTING A POSITIVE RESULT FOR THE N1 TARGET. COMPLAINTS HISTORY REVIEW SHOWED NO OTHER COMPLAINTS FOR FALSE POSITIVE ON THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM PRODUCT LOT K20-180. HOWEVER, THERE IS A COMPLAINT TREND ASSOCIATED TO THE 175UL TIPS USE IN THE TNA 3 EXK KIT. THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM PRODUCT IS NOT SUSPECTED. THE ROOT CAUSE WAS NOT FOUND. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA#1177233) WAS ALREADY INITIATED TO INVESTIGATE THE 175 L TIPS CONTRIBUTION. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WHEN USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF (B)(4)) LOT K20-180 WAS PERFORMED BY THE REVIEW OF THE BATCH HISTORY RECORD, THE REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX SINCE LOT K20-180 WAS TESTED ALONG WITH BD MAX EXK TNA-3 LOT 0114415. THE REVIEW OF THE BATCH HISTORY RECORDS OF THE BIOGX SARS-COV-2 OSR INDICATED THAT K20-180 LOT SHOWS EXPECTED PERFORMANCE. CUSTOMER RUN #734 WAS ANALYZED. CUSTOMER REPORTS N1 FALSE POSITIVE RESULT ON THE BD MAX BUT NEGATIVE WITH OTHER PCR METHODS. ANALYSIS OF THE CURVE ON RUN 734 SHOWS A GLITCH CAUSING AN INTERRUPTION IN BACKGROUND CORRECTION, GENERATING A STEADY INCREASE OF FLUORESCENCE IN THE CURVE, RESULTING A POSITIVE RESULT FOR THE N1 TARGET. COMPLAINTS HISTORY REVIEW SHOWED NO OTHER COMPLAINTS FOR FALSE POSITIVE ON THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM PRODUCT LOT K20-180. THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM PRODUCT IS NOT SUSPECTED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED FOR THE CUSTOMER SPECIFIC ISSUE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT PREVIOUSLY HAD TWO OTHER SARS2 SAMPLES TESTED AT ANOTHER FACILITY AND THE RESULTS WERE NEGATIVE. ADDITIONAL TESTING WAS PERFORMED ON THE POSITIVE SAMPLE AND ALL RESULTS WERE NEGATIVE. THE ERRONEOUS RESULT WAS RELEASED TO THE CLINICIAN, AND THE RESULT REPORT WAS AMENDED. THE CUSTOMER STATED THE PATIENTS¿ ELECTIVE SURGERY WAS DELAYED DUE TO THE ERRONEOUS RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT PREVIOUSLY HAD TWO OTHER SARS2 SAMPLES TESTED AT ANOTHER FACILITY AND THE RESULTS WERE NEGATIVE. ADDITIONAL TESTING WAS PERFORMED ON THE POSITIVE SAMPLE AND ALL RESULTS WERE NEGATIVE. THE ERRONEOUS RESULT WAS RELEASED TO THE CLINICIAN, AND THE RESULT REPORT WAS AMENDED. THE CUSTOMER STATED THE PATIENTS¿ ELECTIVE SURGERY WAS DELAYED DUE TO THE ERRONEOUS RESULTS.

    Additional Manufacturer Narrative · 1

    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 THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT PREVIOUSLY HAD TWO OTHER SARS2 SAMPLES TESTED AT ANOTHER FACILITY AND THE RESULTS WERE NEGATIVE. ADDITIONAL TESTING WAS PERFORMED ON THE POSITIVE SAMPLE AND ALL RESULTS WERE NEGATIVE. THE ERRONEOUS RESULT WAS RELEASED TO THE CLINICIAN, AND THE RESULT REPORT WAS AMENDED. THE CUSTOMER STATED THE PATIENTS¿ ELECTIVE SURGERY WAS DELAYED DUE TO THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754675 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other