BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60

    MDR report key: 23242454 · Received October 8, 2025

    Report

    Report Number
    3003630693-2025-00001
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 5, 2025
    Manufacturer
    CELLAVISION AB
    Product Code
    JOY
    PMA / PMN Number
    K092868
    Removal / Correction Number
    3003630693/10172025/C/00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE INITIAL REPORT WAS SUBMITTED A FIELD CORRECTION HAS BEEN INITIATED ON THE U.S MARKET FOR DEVICES AFFECTED BY THE ISSUE WHICH WAS DISCOVERED THROUGH THE INCIDENT ASSOCIATED WITH THIS REPORT. AFFECTED END-USERS HAVE BEEN NOTIFIED VIA A FILED CORRECTION NOTIFICATION WHICH WAS FIRST SENT ON THE (B)(6) 2025 VIA OUR DISTRIBUTION PARTNER SYSMEX AMERICA INC. FDA HAS BEEN NOTIFIED ACCORDING WITH REPORT REFERENCES THROUGH A RECALL/CORRECTION REPORT WITH THE FOLLOWING IDENTIFIES AND REFERENCES ASSOCIATED: CORRECTION#: (B)(4). FDA ASSIGNED CORRECTION/RECALL REF: (B)(4). FDA ASSIGNED RECALL SUBMISSION NR: (B)(4).

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATIONS ON THE DEVICE, FOLLOWING THE REPORTED INCIDENT, HAS SHOWED THAT THE MALFUNCTION IS CAUSED BY CONDITIONS IN THE FIRMWARE IN COMBINATION WITH NEWER BARCODE READERS. SPECIFICALLY, THE BARCODE READER HAS A FIELD OF VIEW THAT IS TOO LARGE, ALLOWING CAPTURE OF THE BARCODE ON THE RETURN SLIDE. PLANNING OF CORRECTIVE ACTIONS THROUGH FIRMWARE UPDATE IS UNDERWAY. A FOLLOW-UP REPORT SHALL BE SUPPLIED ONCE REMEDIAL ACTION IS INITIATED.

    Description of Event or Problem · 0

    DURING ROUTINE OPERATION OF THE DI-60 ANALYZER (IN A LAB IN FRANCE) AN ERROR WAS OBSERVED IN SLIDE IDENTIFICATION. AFTER ANALYZING SLIDE 1 (WITH QR CODE) AND PLACING IT IN THE RETURN POSITION, THE ANALYZER ATTEMPTED TO READ THE BARCODE OF SLIDE 2 (WITHOUT QR CODE) BUT INSTEAD RE-READ THE QR CODE OF SLIDE 1. CONSEQUENTLY, BOTH SLIDES WERE ASSIGNED THE SAME QR CODE. THE ISSUE WAS DISCOVERED BY THE OPERATOR/HEALTHCARE PROFESSIONAL AT THE TIME OF EVENT AND THUS NO INCORRECT RESULTS WERE REPORTED. THE MANUFACTURER (CELLAVISION AB) WAS MADE AWARE OF THE INCIDENT ON THE 9TH OF SEPTEMBER 2025 AND THROUGH ROOT CAUSE INVESTIGATION IT WAS DISCOVERED THAT IN SOME INSTANCES WHEN A SLIDE HAS AN UNREADABLE BARCODE THERE IS A RISK THAT THE BARCODE READER ACCIDENTALLY READS THE BARCODE OF THE PREVIOUSLY PROCESSED SLIDE, THUS RESULTING IN A MISATTRIBUTION OF DIAGNOSTIC RESULTS. THE PRECONDITION FOR THE ISSUE TO OCCUR IS THAT A SLIDE WITH AN UNREADABLE BARCODE IS RUN AFTER A SLIDE WITH A READABLE BARCODE. IN THIS CASE THERE IS A RISK THAT THE BARCODE READER INSTEAD READS THE BARCODE OF THE SLIDE LOCATED IN THE SHUTTLE RETURN POSITION AND THUS ATTRIBUTES THE RESULTS FROM THE SLIDE IN FETCH POSITION TO THE ID OF THE SLIDE IN RETURN POSITION. IF THE HEALTHCARE PROFESSIONAL PERFORMING THE REVIEW IS NOT ATTENTIVE THIS HAS THE POTENTIAL TO LEAD TO A WRONG DIAGNOSIS. THE MALFUNCTION MAY LEAD TO MISATTRIBUTION OF DIAGNOSTIC RESULTS TO THE WRONG PATIENT. POTENTIAL CONSEQUENCES INCLUDE INDIRECT HARM SUCH AS INCORRECT OR DELAYED DIAGNOSIS, UNNECESSARY OR INAPPROPRIATE TREATMENT, OR DELAY IN APPROPRIATE TREATMENT. DEPENDING ON THE TEST TYPE AND PATIENT CONDITION, THIS COULD RESULT IN SERIOUS CLINICAL OUTCOMES (E.G., LIFE-THREATENING SITUATION, PROLONGED HOSPITALIZATION, OR PERMANENT IMPAIRMENT). AT THE TIME OF REPORTING, NO ADVERSE HEALTH OUTCOMES HAVE BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513068 AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60 AUTOMATED CELL-LOCATING DEVICE JOY CELLAVISION AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown