BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PCR CARTRIDGE

    MDR report key: 20793434 · Received November 27, 2024

    Report

    Report Number
    3007420875-2024-00153
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 24, 2024
    Report Date
    March 14, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    30382904375196
    PMA / PMN Number
    K111860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2: ADDITIONAL MEDICAL DEVICE TYPES: NJR. E1: INITIAL REPORTER PHONE NUMBER: (B)(6). E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. 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 WITH THE BD PCR CARTRIDGES (REF. (B)(4)) LOT 4093507 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX SYSTEM, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX SYSTEM, A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843474 BD PCR CARTRIDGE THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4093507 30382904375196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown