BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSTRUMENT MAX CLINICAL

    MDR report key: 10560138 · Received September 21, 2020

    Report

    Report Number
    1119779-2020-00373
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    September 9, 2020
    Report Date
    December 21, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    OOI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-348 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. THE CUSTOMER COMPARED THE SAME SAMPLES WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 0168240 AND DID NOT OBTAIN THE SAME RESULTS. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-348 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. REVIEW OF THE MANUFACTURING RECORDS OF BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT INDICATED THAT THE LOT 0168240 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED 6 RUNS FILES FROM 2 SAMPLES TAKEN FROM THE SAME PATIENT. IN THREE RUNS (415, 416 AND 418), THE INITIAL PATIENT SAMPLE WAS TESTED, WHEREAS THE REMAINING THREE RUNS (421, 424 AND 425) TESTED A SECOND SAMPLE COLLECTED FROM THE SAME PATIENT. THE RUNS 415, 416 AND 425 WERE PERFORMED BY BD SARS COV-2 REAGENTS AND THE RUNS 418, 421 AND 424 WERE PERFORMED BY BIOGX SARS-COV-2 REAGENTS. THE CUSTOMER¿S UDP SETTINGS FOR THE BIOGX SARS-COV-2 REAGENTS KIT WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE PACKAGE INSERT INSTRUCTION FOR USE. THE UDP OF BD SARS-COV-2 REAGENTS RUN FILES WAS ALSO REVIEWED AND SHOWED THAT THE N2 THRESHOLD WAS NOT SET PROPERLY AS INDICATED IN THE LATEST PACKAGE INSERT VERSION. DESPITE THIS INCORRECT PARAMETER SETTING, NONE OF THE RESULTS ANALYZED HEREIN WERE IMPACTED. NONETHELESS, THE PROPER SETTINGS SHOULD BE UPDATED IN THE CUSTOMER¿S UDP. THE INITIAL SAMPLE WAS TESTED THREE TIMES (RUNS 415, 416 AND 418) WITH DIFFERENT SAMPLE BUFFER TUBES PREPARATIONS AND SHOWED AMPLIFICATION CURVES IN THE N2 CHANNEL (CY5) EVERY TIME, WHICH APPEARED TO BE TRUE AMPLIFICATION CURVES. HOWEVER, ONLY THE SAMPLE FROM RUN 418 WAS VALID, AND THE RESULT APPEARED TO BE A TRUE POSITIVE RESULT. CONTAMINATION OF THE INITIAL SAMPLE CANNOT BE EXCLUDED SINCE SOME CONTROL RUNS HAVE CONTAMINATION (QC NEGATIVE SAMPLE WAS FOUND POSITIVE IN RUN 416 AND RNASE CONTROL IN RUN 415, POSITION B7 WAS POSITIVE FOR THE N2 TARGET). THIS INDICATES SOME CONTAMINATION OCCURRING AT THE CUSTOMER SITE, FURTHER SUPPORTED BY THE FACT THAT ANOTHER RNASE CONTROL, IN RUN 425 (POSITION B11) WAS ALSO POSITIVE FOR N1 AND N2 TARGETS WITH THE BD SARS-COV-2 ASSAY. ALL THE RESULTS FOR THE TESTS WITH THE OTHER SAMPLE COLLECTION (IN RUNS 421, 424 AND 425), WERE NEGATIVE. ANALYSIS OF THE 6 RUNS REVEALED THAT THE POSITIVE RESULTS OBTAINED WERE INDICATIVE OF TRUE AMPLIFICATIONS, POTENTIALLY CAUSED BY EITHER A TRUE POSITIVE SAMPLE AT LOW LEVELS OF TARGET IN THE INITIAL SAMPLE, OR BY CONTAMINATION OF THE SAMPLE DURING ITS PREPARATION. 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 K20-348. 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). EUA #: (B)(4). H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENT FOR BD MAX SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE TEST WAS REPEATED AND UPON REPEAT THE RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND 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). EUA #:(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENT FOR BD MAX SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE TEST WAS REPEATED AND UPON REPEAT THE RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029066 BD INSTRUMENT MAX CLINICAL MOLECULAR DIAGNOSTICS OOI BECTON, DICKINSON & CO. K20-348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other