BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC PARASITE PANEL

    MDR report key: 23350918 · Received October 21, 2025

    Report

    Report Number
    3007420875-2025-00197
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 17, 2025
    Report Date
    December 17, 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

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ ENTERIC PARASITE PANEL (EPP) KIT (REF. 442960) LOT: 5064851 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND THE COMPLAINT¿S HISTORY REVIEW. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ EPP LOT: 5064851 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. CUSTOMER COMPLAINED ABOUT A POSITIVE RESULT FOR THE CRYPTOSPORIDIUM TARGET WITH BD MAX¿ EPP KIT LOT: 5064851 WHICH RESULTED IN A NEGATIVE RESULT UPON RETEST DONE USING A NEW SAMPLE PREPARATION IN A NEW SAMPLE BUFFER TUBE. CUSTOMER PROVIDED THE DATABASE FROM BD MAX¿ INSTRUMENT CT2330 FOR INVESTIGATION AND IDENTIFIED THE AFFECTED SAMPLE AS THE INITIAL TEST IN POSITION A8/RUN (B)(4), AND THE REPEAT TEST IN POSITION A1/RUN 93. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED AND REVEALED EARLY AND STRONG AMPLIFICATION IN THE ROX CHANNEL (CRYPTOSPORIDIUM TARGET) FOR SAMPLE A8 IN RUN 93. THE SAMPLE WAS RETESTED APPROXIMATELY 24 HOURS LATER USING A NEW SAMPLE BUFFER TUBE, AND THE RESULT WAS NEGATIVE, SHOWING NO AMPLIFICATION OTHER THAN THE INTERNAL CONTROL (CY5.5), WITHOUT ANY ISSUE. ACCORDING TO INSTRUCTION FOR USE (IFU), THE SAME SBT MAY BE USED FOR ONE REPEAT WITHIN 48 HOURS OF THE INITIAL INOCULATION IF STORED AT ROOM TEMPERATURE, OR UP TO 5 DAYS IF STORED AT 2¿8°C. HOWEVER, CUSTOMER RETESTED USING A NEW SAMPLE BUFFER TUBE. ERRONEOUS RESULTS CAN OCCUR DUE TO IMPROPER SPECIMEN COLLECTION, HANDLING, STORAGE, TECHNICAL ERRORS, SAMPLE MIX-UPS, OR WHEN THE ORGANISM COUNT IN THE SPECIMEN IS BELOW THE ANALYTICAL SENSITIVITY OF THE TEST. FALSE NEGATIVE RESULTS MAY ALSO RESULT FROM NUCLEIC ACID LOSS CAUSED BY INADEQUATE COLLECTION, TRANSPORT, OR STORAGE OF SPECIMENS, OR INSUFFICIENT ORGANISM LYSIS. THE SAMPLE PROCESSING CONTROL IS INCLUDED IN THE TEST TO HELP IDENTIFY SPECIMENS CONTAINING PCR INHIBITORS. HOWEVER, IT DOES NOT INDICATE WHETHER NUCLEIC ACID WAS LOST DUE TO POOR COLLECTION, TRANSPORT, OR STORAGE, NOR DOES IT CONFIRM IF CELLS WERE INADEQUATELY LYSED. SINCE THE ANALYSIS OF BOTH SAMPLES (RUN 93, SAMPLE A8 AND RUN 95, SAMPLE A1) DID NOT REVEAL ANY ISSUES, BD SUSPECTS THAT THE PROBLEM MAY BE RELATED TO SAMPLE HANDLING OR PREPARATION, HOWEVER THE EXACT CAUSE FOR THE CUSTOMER ISSUE CANNOT 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 KIT LOT: 5064851. 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 (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPE: PCH. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ ENTERIC PARASITE PANEL, A FALSE POSITIVE CRYPTOSPORIDIUM PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236346 BD MAX¿ ENTERIC PARASITE PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5064851 00382904429607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown