BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC PARASITE PANEL

    MDR report key: 21899820 · Received April 24, 2025

    Report

    Report Number
    3007420875-2025-00066
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    March 27, 2025
    Report Date
    June 16, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904429607
    PMA / PMN Number
    K220193
    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 TYPE: PCH. E.1. INITIAL REPORTER PHONE NUMBER: (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 RESULTS WHEN USING THE BD MAX¿ ENTERIC PARASITE PANEL ASSAY (REF# 442960) LOT 4233950 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ ENTERIC PARASITE PANEL ASSAY INDICATED THAT THE LOT 4233950 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT A SUSPECTED FALSE POSITIVE RESULT FOR THE G. LAMBIA TARGET WHEN USING BD MAX¿ ENTERIC PARASITE PANEL KIT LOT 4233950 AND PROVIDED A PICTURE OF RUN #1457 WHICH CONTAINED NINE SAMPLES FOR INVESTIGATION. THE SAMPLE SUSPECTED OF BEING FALSE POSITIVE BY THE CUSTOMER IS IN POSITION B1. THE CORRESPONDING CURVES FOR THIS SAMPLE WERE ISOLATED ON THE PICTURE REPORT PROVIDED BY THE CUSTOMER AND REVEALED STEPS DISLOCATIONS AROUND CYCLE 40 IN FAM AND ROX CHANNELS THAT REACHED THE THRESHOLD TO GIVE A POSITIVE RESULT IN THE FAM CHANNEL (GLAM TARGET). BASED ON THE INVESTIGATION, IT IS UNLIKELY THAT THIS POSITIVE RESULT IS TRUE AMPLIFICATION. NEVERTHELESS, IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. SINCE THE CUSTOMER DID NOT MENTION ANY OTHER EVENT AND CONSIDERING THAT NO OTHER COMPLAINT FOR DISCREPANT RESULTS ISSUES WAS RECEIVED ON THIS LOT, THIS MAY HAVE BEEN AN ISOLATED ISSUE, AND A ROOT CAUSE COULD NOT BE IDENTIFIED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ ENTERIC PARASITE PANEL ASSAY LOT 4233950. 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) SINCE NO TREND 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

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC PARASITE PANEL, A GIARDIA LAMBLIA FALSE POSITIVE PATIENT RESULT WITH AN NOISY PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC PARASITE PANEL, A GIARDIA LAMBLIA FALSE POSITIVE PATIENT RESULT WITH AN NOISY PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192679 BD MAX¿ ENTERIC PARASITE PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4233950 00382904429607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown