BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    MDR report key: 11238576 · Received January 27, 2021

    Report

    Report Number
    3007420875-2021-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    December 31, 2020
    Report Date
    March 1, 2021
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904438128
    PMA / PMN Number
    K170308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX EXTENDED ENTERIC BACTERIAL PANEL (XEBP) (REF. (B)(4)) LOT 0203459 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. CUSTOMER PROVIDED DATA ALLOWING TO IDENTIFY THAT LOT 0290202 OF BD MAX¿ ENTERIC BACTERIAL PANEL (EBP) (REF. 442963) WAS USED WITH THE XEBP LOT. REVIEW OF THE MANUFACTURING RECORDS OF BOTH BD MAX ENTERIC BACTERIAL PANEL LOT 0290202 AND BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL LOT 0203459 KITS INDICATED THAT RESULTS MET THE SPECIFICATIONS FOR RELEASE AND USE. RETAIN MATERIAL OF XEBP KIT LOT 0203459 AND EBP KIT LOT 0290202 WERE TESTED IN NEGATIVE AND NO POSITIVE RESULT WAS OBTAINED FOR THE EBP AND THE XEBP TARGETS. CUSTOMER REPORTED FALSE POSITIVE RESULTS AND PROVIDED ONE RUN FILE (RUN #4392) FROM INSTRUMENT CT0914 FOR INVESTIGATION. IN THIS RUN, FIVE SAMPLES WERE TESTED WITH THE BD MAX¿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¿ EXTENDED ENTERIC BACTERIAL PANEL LOT 0203459. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH KIT BD MAX EXT ENTERIC BACTERIAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT IF REPEAT OR CONFIRMATORY TESTING WAS PERFORMED. PATIENT IMPACT WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING WITH KIT BD MAX EXT ENTERIC BACTERIAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT IF REPEAT OR CONFIRMATORY TESTING WAS PERFORMED. PATIENT IMPACT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132477 KIT BD MAX EXT ENTERIC BACTERIAL PANEL SEE H.10 PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443812 0203459 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1