BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10486304 · Received September 2, 2020

    Report

    Report Number
    1119779-2020-00306
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 10, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0160157. D.4. MEDICAL DEVICE EXPIRATION DATE: 11/28/2020. H.4. DEVICE MANUFACTURE DATE: 6/8/2020. H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM (B)(4) LOT 0160157 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 MAX SARS COV-2 INDICATED THAT THE QC RESULTS WERE COMPLIANT. CUSTOMER REPORTED A POSITIVE RESULT FOR N1 TARGET ON ONE SAMPLE (RUN #104, LANE B11) BUT AFTER FURTHER CURVE INTERPRETATION, IT WAS DETERMINED NEGATIVE. CUSTOMER PROVIDED RUN #104 FOR ANALYSIS. BD ANALYSIS OF CURVE SHOW A TRUE AMPLIFICATION FOR BOTH N1 AND N2 TARGETS. HOWEVER, THE N2 CURVE DID NOT PASSED THE THRESHOLD TO GAVE POSITIVE RESULTS WHILE THE N1 CURVE PASSED THE THRESHOLD BUT IS NOISY. THE MOST PROBABLE CAUSE IS THAT THE SAMPLE WAS A LOW POSITIVE SAMPLE, AT THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR A CONTAMINATION. THERE IS NO COMPLAINT TREND FOR FALSE POSITIVE RESULT FOR THE BD SARS-COV-2 LOT 0160157. THE ROOT CAUSE FOR THE FALSE POSITIVE RESULT WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER DETERMINED THAT THE RESULT WAS ERRONEOUS BY ANALYZING THE CURVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: EUA (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER DETERMINED THAT THE RESULT WAS ERRONEOUS BY ANALYZING THE CURVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949989 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. 0160157

    Patients

    Seq Age Sex Outcome Treatment
    1 Other