BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    MDR report key: 12469144 · Received September 14, 2021

    Report

    Report Number
    1119779-2021-01501
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 17, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT (REF. (B)(4)) LOTS 1125568 AND 1120402 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM INDICATED THAT LOTS 1125568 AND 1120402 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED POTENTIAL FALSE COV2 POSITIVE RESULTS OCCURRING AT LOW RATES. MANY RUNS WERE MENTIONED AND PROVIDED. UPON EXAMINATION OF THE DATA THE COMPLAINT IS RELATED TO LOT #1125568 AND LOT 1120402 (USED FOR ONE CONFIRMATION TEST). BOTH LOTS WERE THUS INCLUDED IN THE INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM INSTRUCTION FOR USE. MANUAL CURVES ADJUDICATION WAS CONDUCTED ON ALL THE SAMPLES MENTIONED IN THE COMPLAINT. CURVES OF ALL THE SAMPLES SHOWED TRUE BUT LOW AMPLIFICATION, WITHOUT ANOMALY. IN SOME CASES, LOW CURVES WERE ALSO DETECTABLE IN THE CY5 CHANNEL (N2 TARGET) BUT BELOW THRESHOLD FOR THIS TARGET, THUS NOT RESULTING IN A POSITIVE RESULT FOR N2. 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 AND/OR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. BD WAS UNABLE TO FIND THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. OVERALL, NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM LOTS 1125568 AND 1120402. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 96 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEMS EXPERIENCED FALSE POSITIVES. PRODUCT DEFECT OCCURRED DURING TESTING FOR SARS COV-2.THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 2 SAMPLES IN RUN 4216 WERE REPEATED IN RUN 4217, SAMPLE (B)(6) WAS NEGATIVE BUT (B)(6) WAS STILL N1 POSITIVE. RUN 1896 WITH THE 2 EXAMPLES ARE THE SAME PATIENT BUT DIFFERENT SWABS.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1125568. MEDICAL DEVICE EXPIRATION DATE: 2021-11-12. DEVICE MANUFACTURE DATE: 2021-05-05. MEDICAL DEVICE LOT #: 1120402. MEDICAL DEVICE EXPIRATION DATE: 2021-11-19. DEVICE MANUFACTURE DATE: 2021-04-30. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 96 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEMS EXPERIENCED FALSE POSITIVES. PRODUCT DEFECT OCCURRED DURING TESTING FOR SARS COV-2. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 2 SAMPLES IN RUN (B)(6) WERE REPEATED IN RUN (B)(6), SAMPLE (B)(6) WAS NEGATIVE BUT (B)(6) WAS STILL N1 POSITIVE. RUN (B)(6) WITH THE 2 EXAMPLES ARE THE SAME PATIENT BUT DIFFERENT SWABS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368068 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown