BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PCR CARTRIDGE

    MDR report key: 20857294 · Received December 5, 2024

    Report

    Report Number
    3007420875-2024-00175
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    October 24, 2024
    Report Date
    March 13, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    30382904375196
    PMA / PMN Number
    K111860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: NJR. E.1. (B)(6). 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 AND UNRESOLVED (UNR) RESULTS WITH THE BD MAX MDR-TB (REF. (B)(4), LOT: 4192228 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT AN INCREASE RATE OF LOW SIGNALS FOR THE IC TARGET WHEN USING BD MAX MDR-TB KIT LOT: 4192228. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX MDR-TB INDICATED THAT THE LOT: 4192228 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUNS (B)(4), AND DATABASE FROM INSTRUMENT CM0080 FOR INVESTIGATION. IN THE DATA PROVIDED, 12 SAMPLES PRESENTED A RESULT ISSUE THAT MATCHED THE COMPLAINT TEXT DESCRIPTION. 11 OF THOSE SAMPLES TESTED UNR FOR THE MTB TARGET. ALL THE SAMPLES THAT WERE TESTED (10) GAVE A VALID MTB NOT DETECTED RESULT. UNR RATE OBTAINED BY THE CUSTOMER FOR MDR-TB KIT LOT: 4192228 IS OF 2.8% WHICH IS WITHIN PI CLAIMS (1.5%-4.0%). ANALYSIS ALSO REVEALED NO DIFFERENCE BETWEEN MDR-TB KIT LOTS USED BY THE CUSTOMER FOR THE MEAN EP AND MEAN CT VALUES SUGGESTING NO REAGENT ISSUE WITH THE MDR-TB KIT LOT: 4192228. 1 SAMPLE GAVE AN MTB NOT DETECTED RESULT (CT 38.4) OF THAT REPEATED MTB DETECTED (CT 33.7) AS DESCRIBED IN THE COMPLAINT TEXT. PCR CURVES ADJUDICATION WAS CONDUCTED ON THE SAMPLE WHICH GAVE AN MTB NOT DETECTED RESULT AND REVEALED LATE AND LOW AMPLIFICATION IN THE FAM CHANNEL IN BOTTOM POSITION OF THE CARTRIDGE (IC) THAT REACHED THE THRESHOLD TO GIVE A VALID RESULT, AND A LOW AMPLIFICATION IN THE VIC CHANNEL IN THE BOTTOM POSITION OF THE CARTRIDGE (DEVR TARGET) AND NO AMPLIFICATION IN THE FAM CHANNEL IN THE TOP POSITION OF THE CARTRIDGE (IS TARGET), BOTH DID NOT REACHED THE THRESHOLD TO GIVE A POSITIVE RESULT. AN MTB NOT DETECTED RESULT WAS THE EXPECT RESULT IN SUCH A CASE. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR UNR OR DISCREPANT RESULTS ON BD MAX MDR-TB LOT: 4192228. 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 SINCE NO NEW HAZARD OR TRENDS WERE 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

    IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX SYSTEM, A NEGATIVE MDR-TB PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED ON MAX AND WAS MDR-TB POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX SYSTEM, A NEGATIVE MDR-TB PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED ON MAX AND WAS MDR-TB POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296596 BD PCR CARTRIDGE THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4121669 30382904375196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown