BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ EXK¿ DNA-1

    MDR report key: 21382032 · Received February 13, 2025

    Report

    Report Number
    3007420875-2025-00034
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 15, 2025
    Report Date
    May 5, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    JJH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ EXK¿ DNA-1 KIT (REF. 442817) KIT LOT 4233954 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT UNEXPECTED POSITIVE RESULTS FOR THE EHRLICHIA TARGET WITH THEIR OPEN SYSTEM ASSAY (TICK ASSAY), WHEN USING THE BD MAX¿ EXK¿ DNA-1 KIT LOT 4233954. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ EXK¿ DNA-1 KIT INDICATED THAT LOT 4233954 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED DATABASE AND RUN FILES (CSV AND PDF) OF RUNS 249, 253, 254, 262, 264, 265, 270, 271 AND 272 FROM BD MAX¿ INSTRUMENT CT3345 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE POSITIVE EHRLICHIA SAMPLES. ANALYSIS OF THE PCR CURVE FOR SAMPLE A2 IN RUN 265 SHOW STEP DISLOCATIONS IN THE RAW PCR SIGNAL FOR THE EMURWL TARGET CHANNEL (ROX), THE ANAP TARGET CHANNEL (CY5) AND THE INTERNAL CONTROL (CY5.5), RESULTING IN A POSITIVE RESULT FOR THE EMURWL TARGET. IT IS UNLIKELY THAT THE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION AND A ROOT CAUSE COULD NOT BE IDENTIFIED. ANALYSIS OF THE PCR CURVE FOR SAMPLE A2 IN RUN 262 SHOWS A LATE AND LOW AMPLIFICATION WITHOUT ANOMALY INDICATIVE OF TRUE LOW POSITIVE RESULTS. THE INTERNAL CONTROL AMPLIFICATION SHOWS NO ANOMALY. LOW POSITIVE SAMPLES CAN OCCUR DUE TO BACTERIAL 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. FOR THE FOUR REMAINING SAMPLES (RUNS 254, POSITION A5, RUN 264, POSITION A6, RUN 271, POSITIONS A9 AND A10), AN UPWARD DRIFT CAN BE OBSERVED IN RAW PCR AND BACKGROUNDED SIGNALS CAUSING THE EMURWL POSITIVE RESULTS. THE CURVES DO NOT SUGGEST TRUE AMPLIFICATION. HOWEVER, BD IS UNABLE TO IDENTIFY THE CAUSE FOR THESE UPWARD DRIFTING CURVES. FURTHER ANALYSIS REVEALED THE ISSUE OCCURRED WHILE USING 2 DIFFERENT LOTS OF BD PCR CARTRIDGES, AND TWO DIFFERENT BD MAX¿ EXK¿ DNA-1 KIT LOTS, SUGGESTING THAT THE ISSUE IS NOT LINKED TO SPECIFIC CARTRIDGE NOR KIT LOTS. NO EMURWL SUSPECTED FALSE POSITIVE RESULT WAS OBTAINED IN RUNS 249, 253 AND 272, UPON MANUAL PCR CURVES ADJUDICATION. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND ABERRANT CURVE GEOMETRY ARE A CONSERVATIVE ASSESSMENT OF THE DATA. OVERALL, BASED ON THE INVESTIGATION, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ EXK¿ DNA-1 KIT LOT 4233954. 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 PLAN SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    REPORT 2 OF 4: IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXK¿ DNA-1, A FALSE POSITIVE PATIENT RESULT FOR THE CUSTOMER'S OPEN SYSTEM TICK ECHRLICHIA ASSAY WAS OBTAINED. SAMPLE WAS REPEATED, AND GAVE NEGATIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 2 OF 4: IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXK¿ DNA-1, A FALSE POSITIVE PATIENT RESULT FOR THE CUSTOMER'S OPEN SYSTEM TICK ECHRLICHIA ASSAY WAS OBTAINED. SAMPLE WAS REPEATED, AND GAVE NEGATIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460094 BD MAX¿ EXK¿ DNA-1 NUCLEIC ACID EXTRACTION/ISOLATION KIT IVD JJH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4233954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown