BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC BACTERIAL PANEL

    MDR report key: 18275381 · Received December 6, 2023

    Report

    Report Number
    3007420875-2023-00116
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 9, 2023
    Report Date
    January 31, 2024
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCI
    UDI-DI
    00382904429638
    PMA / PMN Number
    K140111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER LAST NAME: (B)(6). E.1. INITIAL REPORTER PHONE NUMBER: (B)(6). E.1. INITIAL REPORTER E-MAIL: (B)(6). H.3. 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 SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY ((B)(4)) FROM LOT 3172498 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT LOT 3172498 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD MAX¿ ENTERIC BACTERIAL PANEL (EBP) ASSAY FROM LOT 3172498 WAS TESTED AND THE RESULTS WERE AS EXPECTED, WITHOUT ANY ANOMALY. THE REAGENTS PERFORMED WITHIN SPECIFICATIONS. CUSTOMER COMPLAINED ABOUT DISCREPANCIES FOR TWO DISTINCT SAMPLES WHEN COMPARED WITH ALTERNATE METHODS. A FIRST SAMPLE RECEIVED A NEGATIVE RESULT FOR SALMONELLA TARGET BUT TESTED POSITIVE BY CONVENTIONAL CULTURE WHILE A SECOND SAMPLE RECEIVED A NEGATIVE RESULT FOR CAMPYLOBACTER TARGET BUT RESULTED IN A POSITIVE WITH AN ANTIGEN TEST. CUSTOMER PROVIDED NO FURTHER INFORMATION CONCERNING THE SPECIFIC SAMPLES INVOLVED IN THE ISSUE, AND SPECIFIC ANALYSIS COULD NOT BE PERFORMED. HOWEVER, CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT0543 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL SAMPLES TESTED WITH BD MAX¿ EBP ASSAY KIT LOT #3172498. ANALYSIS OF PCR CURVES OF ALL SAMPLES SHOWED NO SIGN OF PCR AMPLIFICATION FOR ANY EBP TARGETS, AND A STRONG AMPLIFICATION OF INTERNAL CONTROL (CY5.5 CHANNEL), RESULTING IN NEGATIVE RESULTS, WITHOUT ANOMALY. BASED ON THIS CURVES ANALYSIS, NO REAGENTS ISSUE FOR ANY OF THE SAMPLES IS SUSPECTED. ACCORDING TO THIS DATA AND CONSIDERING THE FACT THE RETAIN MATERIAL TESTING SHOWED THAT KIT LOT #3172498 STILL PERFORMS AS EXPECTED, NO REAGENTS ISSUE IS SUSPECTED. OVERALL, BASED ON THE INVESTIGATION AND AVAILABLE INFORMATION, THE ROOT CAUSE WAS NOT IDENTIFIED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOT 3172498. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 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

    1 OF 2. IT WAS REPORTED THAT PATIENT SAMPLES TESTED WITH THE BD MAX¿ ENTERIC BACTERIAL PANEL GAVE FALSE NEGATIVE RESULTS FOR SALMONELLA AND CAMPYLOBACTER. SAMPLES WERE NOT REPORTED OUT SO THERE WAS NO PATIENT IMPACT. CONFIRMATORY TESTS WERE PERFORMED: SAMPLE 1: CONVENTIONAL CULTURE POSITIVE FOR SALMONELLA.

    Description of Event or Problem · 0

    1 OF 2. IT WAS REPORTED THAT PATIENT SAMPLES TESTED WITH THE BD MAX¿ ENTERIC BACTERIAL PANEL GAVE FALSE NEGATIVE RESULTS FOR SALMONELLA AND CAMPYLOBACTER. SAMPLES WERE NOT REPORTED OUT SO THERE WAS NO PATIENT IMPACT. CONFIRMATORY TESTS WERE PERFORMED: SAMPLE 1: CONVENTIONAL CULTURE POSITIVE FOR SALMONELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845826 BD MAX¿ ENTERIC BACTERIAL PANEL GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 3172498 00382904429638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown