BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ MRSA XT

    MDR report key: 13031535 · Received December 17, 2021

    Report

    Report Number
    3007420875-2021-00065
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    November 24, 2021
    Report Date
    February 9, 2022
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    NQX
    UDI-DI
    00382904434618
    PMA / PMN Number
    K133605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE KIT BD MAX MRSA XT (REF. (B)(4)) LOT 1203082 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX MRSA XT INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE RETAIN MATERIAL OF BD MAX MRSA XT FROM LOT 1203082 WAS TESTED IN POSITIVE. ALL REACTIONS GAVE POSITIVE RESULTS, AS EXPECTED. CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON A PATIENT SAMPLE WITH THE BD MAX¿ MRSA XT ASSAY FROM LOT 1203082. THE SAMPLE WAS RETESTED WITH THE GENEXPERT MRSA ASSAY AND GAVE A MRSA POSITIVE RESULT. CUSTOMER PROVIDED ONE RUN FILE (#4842) FROM INSTRUMENT CT0741 FOR INVESTIGATION. RUN 4842 CONTAINED 11 SAMPLES TESTED WITH THE BD MAX¿ MRSA XT ASSAY LOT 1203082. SAMPLE ANALYZED IN POSITION B11, IDENTIFIED AS FALSE NEGATIVE BY THE CUSTOMER, GAVE A MRSA NEGATIVE RESULT. MANUAL CURVES ADJUDICATION WAS PERFORMED FOR THIS SAMPLE AND REVEALED A TRUE AMPLIFICATION IN THE MREJ TARGET (FAM CHANNEL) AND NO AMPLIFICATION IN THE ROX CHANNEL. SINCE BOTH TARGETS MUST AMPLIFY IN ORDER TO GIVE A MRSA POSITIVE RESULT, IT EXPLAINS WHY THIS SAMPLE RESULTED IN A NEGATIVE RESULT. NO ANOMALY WAS OBSERVED IN THE CURVES. AS MENTIONED IN THE PACKAGE INSERT, RESULTS SUCH AS THOSE OBTAINED FOR THIS SAMPLE COULD CORRESPOND TO A MECA/C DROP OUT S. AUREUS STRAIN. HOWEVER, SINCE NO SAMPLE WAS RECEIVED FOR THE INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THIS HYPOTHESIS. OVERALL, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX MRSA XT KIT LOT 1203082. THE ROOT CAUSE WAS NOT IDENTIFIED. IS IT POSSIBLE THAT THE DISCREPANT RESULTS CAN BE EXPLAINED BY A MECA/C DROP OUT S. AUREUS STRAIN. THE REAGENTS ARE NOT SUSPECTED OF BEING IN CAUSE. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ MRSA XT A FALSE NEGATIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE NEGATIVES. 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: " IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A FALSE NEGATIVE RESULT WHILE USING CAT 443461 LOT 1203082. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ MRSA XT A FALSE NEGATIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE NEGATIVES. 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: "IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A FALSE NEGATIVE RESULT WHILE USING CAT 443461 LOT 1203082."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926339 BD MAX¿ MRSA XT SYSTEM, NUCLEIC ACID AMPLIFICATION TEST NQX GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443461 1203082 00382904434618

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown