BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCODE® MDX 3000

    MDR report key: 15256349 · Received August 18, 2022

    Report

    Report Number
    3007799234-2022-00005
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 19, 2022
    Report Date
    August 18, 2022
    Manufacturer
    APPLIED BIOCODE, INC.
    Product Code
    OOI
    UDI-DI
    851034007004
    PMA / PMN Number
    K180041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE REFERENCE: (B)(4). ABC'S TECHNICAL SERVICE (TS) IMMEDIATELY ESCALATED THE REVIEW OF THIS ISSUE TO THE ENGINEERING DEPARTMENT AND BEGAN TO MONITOR THE END USER'S DATA TO CONFIRM RESULTS PRIOR TO THE END USER REPORTING THEM OUT. PRELIMINARY MONITORING BY TS FROM 19-JUL-2022 TO 12-AUG-2022 FOUND THERE HAD BEEN NO OCCURRENCES OF DARK IMAGES. HOWEVER, A REVIEW OF THE RUN ON 15-AUG-2022 FOUND THERE HAD BEEN THREE SAMPLES WITH DARK IMAGES. THIS WAS IMMEDIATELY COMMUNICATED TO THE END-USER. GIVEN THE ISSUE IS STILL OCCURRING SPORADICALLY, ABC'S TS IS EXPLORING FURTHER EVALUATION OPTIONS WHILE IT CONTINUES TO WORK ON THE PREVIOUSLY IDENTIFIED SOFTWARE UPGRADE IMPROVEMENT THAT IS BELIEVED TO PROVIDE A RESOLUTION TO THIS ISSUE. ABC'S TS CONTINUES TO BE IN CONSTANT COMMUNICATION WITH THE END USER WHICH INCLUDES A REMOTE REVIEW OF ALL THEIR RUNS TO VERIFY ACCEPTANCE RESULTS PRIOR TO RELEASING AS PART OF THE CONTINUED MONITORING EFFORTS. ADDITIONALLY, TS PERFORMED A REMOTE ANALYSIS OF ALL OTHER ABC ANALYZERS IN THE FIELD AND DID NOT IDENTIFY DARK FIELD IMAGES ON THOSE SYSTEMS. A REVIEW OF THE PRODUCT HISTORY RECORD (PHR) FOR SN: (B)(4) WAS PERFORMED AND FOUND THAT ANY PARTS WHICH WERE REPLACED DURING THE MANUFACTURING PROCESS OR DEVIATIONS WERE WELL DOCUMENTED ON THE PHR. IN SUMMARY, ALL TESTING ACTIVITIES WERE VERIFIED TO MEET SPECIFICATIONS PRIOR TO PRODUCT RELEASE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED APPLIED BIOCODE (ABC) TECHNICAL SERVICE (TS) TO REPORT THEY HAD ONE SAMPLE WITH THREE FALSE POSITIVE RESULTS. THEY WERE QUESTIONING THE RESULTS SINCE THEY HAVE RECENTLY BEEN EXPERIENCING DARK FIELD IMAGES. ALTHOUGH, THERE ARE NO KNOWN ERRONEOUS RESULTS TO HAVE BEEN REPORTED, THIS ISSUE IS BEING REPORTED TO FDA OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847747 BIOCODE® MDX 3000 REAL TIME NUCLEI ACID AMPLIFICATION SYSTEM OOI APPLIED BIOCODE, INC. MDX 3000 PI-01015 851034007004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown