BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10388341 · Received August 10, 2020

    Report

    Report Number
    2243072-2020-01222
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 22, 2020
    Report Date
    October 12, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. ¿ SPARKS, MD / 21152. G.2 MANUFACTURING LOCATION: BECTON, DICKINSON & CO. ¿ SPARKS, MD / 21152.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (REF 44500301) LOT 0154891 WAS PERFORMED BY CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. BD HAS RECEIVED SEVERAL OTHER CUSTOMER COMPLAINTS FOR WEAK N2 POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM. MOST OF THESE COMPLAINTS CONCERNED ATYPICAL CURVES, WITH LOW ENDPOINTS. THE CURRENT INVESTIGATION CONCERNS MULTIPLE LOTS OF BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KITS MIXED WITH MULTIPLE LOTS OF BD MAX¿ EXK¿ TNA-3 ASSAY KITS. ANALYSIS OF THE VARIOUS DATABASES RECEIVED FROM CUSTOMERS REVEALED EVIDENCE OF SIMILAR PATTERNS. ALL THE RUNS ANALYZED SHOWED PRESENCE OF BACKGROUND NOISE CAUSED BY SIGNAL DRIFT IN THE CY5 CHANNEL, WITH THE N2 TARGET CAUSING AN INTERRUPTION IN BACKGROUND CORRECTION, GENERATING A STEADY INCREASE OF FLUORESCENCE IN THE CURVES, RESULTING IN FALSE POSITIVE RESULTS. IN ALL CASES, CONTRIBUTING FACTORS INCLUDED THE INSTRUMENT IN COMBINATION WITH THE USER DEFINED PROTOCOL (UDP) PROGRAMMING AND PRODUCT DESIGN. COMPLAINT VERIFICATION SHOWED A COMPLAINT TREND ON BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM LOTS FOR FALSE POSITIVE RESULTS. THE ROOT CAUSE IS UNDER INVESTIGATION AND WILL BE DOCUMENTED IN OUR QUALITY SYSTEM. BD CONFIRMS THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA#1632720) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (EUA (B)(4) A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONAL. THE CUSTOMER NOTICED THE CURVE WAS IRREGULAR AND DID NOT REPORT OUT THE POSITIVE RESULT. THERE WAS NO REPORT OF IMPACT TO PATIENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (EUA# (B)(4)) A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONAL. THE CUSTOMER NOTICED THE CURVE WAS IRREGULAR AND DID NOT REPORT OUT THE POSITIVE RESULT. THERE WAS NO REPORT OF IMPACT TO PATIENTS.

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (EUA#200159) A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONAL. THE CUSTOMER NOTICED THE CURVE WAS IRREGULAR AND DID NOT REPORT OUT THE POSITIVE RESULT. THERE WAS NO REPORT OF IMPACT TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853369 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. 0154891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other