BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM

    MDR report key: 17638136 · Received August 28, 2023

    Report

    Report Number
    3007420875-2023-00081
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    January 22, 2023
    Report Date
    August 18, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    QOF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM (REF: 445215). LOT 2229195 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM INDICATED THAT LOT 2229195 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED A COV-2 POSITIVE RESULT ON PATIENT SAMPLE WITH BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM KIT FROM LOT 2229195 WHICH PREVIOUSLY GAVE A NEGATIVE RESULT WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM ON THE SAME DAY. CUSTOMER PROVIDED ONE PDF FILE SHOWING THE CURVE OF THE POSITIVE COV-2 RESULT OBTAINED WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM. A LIMITED MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ON THE SAMPLE, FROM THE PDF FILE, WHICH SHOWS A LATE BUT TRUE AMPLIFICATION OF THE COV-2 TARGET. ONLY RNASEP CURVES ARE AVAILABLE FOR THE NEGATIVE COV-2 RESULT OBTAINED WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, THUS ANALYSIS OF THIS RESULT IS NOT POSSIBLE. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM LOT 2229195. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, POSITIVE SAMPLE AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) CAN EXPLAIN THE CUSTOMER¿S POSITIVE RESULT. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM PATIENT SAMPLE RESULT DISCREPANCY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE COVID TEST COMES OUT NEGATIVE IN SARSCOV2 PANEL AND POSITIVE WITH RESPIRATORY FLU COVID RVP PANEL. PATIENT SAMPLE TESTED: COVID NEGATIVE WITH BD MAX SARS-COV-2 - 44500301 (CT0937, RUN 7371, 22JAN23), BUT COVID POSITIVE WITH BD MAX RESPIRATORY VIRAL PANEL - 445215 (CT0937, RUN 7374, 22JAN23 ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000131 BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM NA QOF BECTON DICKINSON & CO. (SPARKS) 2229195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown