BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC VIRAL PANEL

    MDR report key: 20977672 · Received December 19, 2024

    Report

    Report Number
    3007420875-2024-00199
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    December 3, 2024
    Report Date
    February 3, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    PMA / PMN Number
    K220607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT: 3007420875-2024-00199 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION. AFTER FURTHER REVIEW OF FILES BY BD QES, IT WAS DETERMINED THAT THIS WAS NOT AN ASSAY ISSUE, BUT AN INSTRUMENT ISSUE. SOFTWARE MUST BE UPDATED TO THE FAN LYSIS SCRIPT TO RESOLVE CUSTOMER FALSE POSITIVES. CANCELING THIS COMPLAINT AND ASSOCIATED MDRS. NEW COMPLAINT AND MDRS FOR INSTRUMENT ARE UNDER (B)(4) - MAX - 441916 - CT2641 - EVP FPS.

    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

    REPORT 3 OF 6: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 3 OF 6: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ ENTERIC VIRAL PANEL, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951052 BD MAX¿ ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4194283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown