BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10388436 · Received August 10, 2020

    Report

    Report Number
    2243072-2020-01223
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    August 5, 2020
    Report Date
    October 14, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 445003) UNKNOWN LOT WAS PERFORMED BY VERIFICATION OF COMPLAINTS HISTORY. BD HAS RECEIVED SEVERAL OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUE WITH THE BD SARS-COV-2 ASSAY, FOR FALSE POSITIVE RESULTS. REVIEW OF CUSTOMER¿S DATA REVEALED A COMMON ISSUE FOR ALL, RELATED TO THE PRODUCT DESIGN ISSUES, COMBINED TO A CONTRIBUTION FROM THE INSTRUMENT. ANALYSIS OF THE VARIOUS DATABASES RECEIVED FROM CUSTOMERS SHOWED ATYPICAL CURVES FOR N1/N2 TARGET, WITH A STEADY INCREASE IN FLUORESCENCE WHICH GENERATED A CT SCORE AND CONSEQUENTLY POSITIVE RESULTS. THESE CURVES DO NOT SEEM LIKE TRUE AMPLIFICATION AND COULD BE LINKED TO A KNOW PRODUCT DESIGN ISSUE OF A HIGH LEVELS OF BACKGROUND NOISE IN ALL CHANNEL WITH BD SARS-COV-2 REAGENTS. MOREOVER, THESE ATYPICAL CURVES COULD HAVE BEEN CAUSED BY THE 175 ¿L TIPS INCLUDED IN THE KITS, SINCE THESE TIPS WERE IDENTIFIED AS A POTENTIAL SOURCE OF EMPTY OR PARTIALLY FILLED PCR CARTRIDGE WELLS, WHICH MAY GENERATE SUCH CURVES. COMPLAINT VERIFICATION SHOWED A COMPLAINT TREND ON BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM LOTS FOR FALSE POSITIVE RESULTS. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA#1632720) WAS INITIATED TO INVESTIGATE THE ROOT CAUSE OF THE HIGH BACKGROUND FLUORESCENCE VALUES AND SOME MITIGATION ACTIONS ARE ALREADY IN PROCESS. IN ADDITION TO THAT A CORRECTIVE AND PREVENTIVE ACTION, CAPA#1177233, IS ALREADY INITIATED TO INVESTIGATE THE 175 ¿L TIPS CONTRIBUTION. 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) 6 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. CONFIRMATORY TESTING WAS PERFORMED USING A DIFFERENT TEST METHOD AND THE RESULTS WERE NEGATIVE. THE POSITIVE RESULTS WERE INITIALLY PERCEIVED TO BE CORRECT. PATIENTS WERE NOT TREATED BASED OFF OF THE ERRONEOUS RESULTS, BUT WERE QUARANTINED UNTIL THE CONFIRMATORY TEST CAME BACK NEGATIVE THE NEXT DAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (EUA# 200159) 6 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. CONFIRMATORY TESTING WAS PERFORMED USING A DIFFERENT TEST METHOD AND THE RESULTS WERE NEGATIVE. THE POSITIVE RESULTS WERE INITIALLY PERCEIVED TO BE CORRECT. PATIENTS WERE NOT TREATED BASED OFF OF THE ERRONEOUS RESULTS, BUT WERE QUARANTINED UNTIL THE CONFIRMATORY TEST CAME BACK NEGATIVE THE NEXT DAY.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: (B)(4). EUA# (B)(4). 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 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (EUA# 200159) 6 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. CONFIRMATORY TESTING WAS PERFORMED USING A DIFFERENT TEST METHOD AND THE RESULTS WERE NEGATIVE. THE POSITIVE RESULTS WERE INITIALLY PERCEIVED TO BE CORRECT. PATIENTS WERE NOT TREATED BASED OFF OF THE ERRONEOUS RESULTS, BUT WERE QUARANTINED UNTIL THE CONFIRMATORY TEST CAME BACK NEGATIVE THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853200 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other