BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12256203 · Received July 30, 2021

    Report

    Report Number
    1119779-2021-01260
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    June 8, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 1103556 AND 1075135 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 1103556 AND 1075135 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED N1 POSITIVE RESULTS WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, WHILE USING KIT LOTS 1103356 AND 1075135, WHICH GAVE A NEGATIVE RESULT UPON REPEAT. CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT1833 FOR 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 PCR CURVE ADJUDICATION WAS PERFORMED ACROSS ALL POSITIVE RESULT IN WHICH ONLY N1 TARGET WAS DETECTED AND USING LOTS 1103356 AND 1075135. ANALYSIS OF PCR CURVES REVEALED LATE AND LOW BUT TRUE N1 AMPLIFICATION, INDICATIVE OF LOW N1 POSITIVE RESULTS. ANALYSIS OF THE OVERALL N1 POSITIVE RESULTS, OBTAINED WITH ALL THE KIT LOTS USED BY THE CUSTOMER, WAS ALSO DONE AND DID NOT REVEAL ANY ISSUE WITH A SPECIFIC KIT LOT. INDEED, LOW POSITIVE N1 RESULTS WERE OBTAINED WITH VARIOUS LOTS, NOT ONLY 1103356 AND 1075135, SUGGESTING THAT WHAT IS OBSERVED IS NOT ASSOCIATED WITH A SPECIFIC LOT. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) 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. NO REPEAT TEST WAS FOUND FOR THESE SAMPLES. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) OR ENVIRONMENTAL OR CROSS CONTAMINATION ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. 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 1103556 AND 1075135. THE ROOT CAUSE WAS NOT IDENTIFIED. NOTE THAT POSITIVES SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY OR A THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE CAN EXPLAIN THE CUSTOMER DISCREPANT SAMPLES. 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 WHILE TESTING FOR SARS COV-2 26 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POS RESULTS (N1+/N2-) NOT REPRODUCABLE, WEAK POSITIVE RESULTS WERE ALWAYS NEGATIVE AFTER REPETITION.".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1103356, MEDICAL DEVICE EXPIRATION DATE: 2021-10-22, DEVICE MANUFACTURE DATE: 2021-04-13. MEDICAL DEVICE LOT #: 1075135, MEDICAL DEVICE EXPIRATION DATE: 2021-10-01, DEVICE MANUFACTURE DATE: 2021-03-16. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 26 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POS RESULTS (N1+/N2-) NOT REPRODUCABLE, WEAK POSITIVE RESULTS WERE ALWAYS NEGATIVE AFTER REPETITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149126 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown