BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVFLO ROUTINE I-TAPED-YELLOW 1000

    MDR report key: 22333395 · Received June 25, 2025

    Report

    Report Number
    1419341-2025-00030
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 31, 2025
    Report Date
    October 30, 2025
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.
    Product Code
    IDZ
    UDI-DI
    20849832022446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED ACTIVFLO ROUTINE I-TAPED-YELLOW 1000, P/N: 39LC-500-9-L, LOT: 20240716 WAS POPPING OPEN. THE SMALL PLASTIC LOCKING PIECES ON THE FRONT OF THE CASSETTE ARE WEAKER THAN USUAL AND HAVE BEEN BREAKING OR NOT STRONG ENOUGH TO LOCK PROPERLY. NO ADVERSE EVENTS WERE REPORTED. TRENDING ANALYSIS FROM 13 JUN 2024 TO 13 JUN 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. THE PRODUCT HISTORY WAS REVIEWED AND DID NOT IDENTIFY ANY INFORMATION IN THE MANUFACTURING RECORD FOR THIS PRODUCT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PROBLEM REPORTED IN THIS COMPLAINT. AS MANUFACTURER INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS, THE ROOT CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER TESTING OF RETAIN SAMPLES WAS UNABLE TO REPLICATE THE "YELLOW CASSETTES "POPPING" BACK OPEN" REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "YELLOW CASSETTES "POPPING" BACK OPEN" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE AWARENESS DATE FOR SUBMISSION 1419341-2025-00030 WAS INCORRECTLY ENTERED IN SECTION G3/4. THE CORRECT DATE WAS 30 MAY 2025.

    Description of Event or Problem · 0

    ON 31 MAY 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "THE PA'S HAVE BEEN HAVING ISSUES WITH THE YELLOW CASSETTES "POPPING" BACK OPEN. SEEMS LIKE THE SMALL PLASTIC LOCKING PIECES ON THE FRONT OF THE CASSETTE ARE WEAKER THAN USUAL AND HAVE BEEN BREAKING OR NOT STRONG ENOUGH TO LOCK PROPERLY." ON (B)(6) 2025, THE CUSTOMER ADVISED "THERE WAS NO LOSS OF TISSUE. THE ISSUE WAS NOTICED AT GROSSING. THE LIDS WOULD KEEP POPPING BACK OPEN, SO THEY¿D PRINT NEW CASSETTES UNTIL THEY GOT SOME THAT STAYED CLOSE. IT ONLY WAS AN ISSUE AT GROSSING. NO RE BIOPSY NEEDED. IT WAS ALL TYPES OF OUR RUSH CASES: BREAST, LUNG, KIDNEY, COLON ETC." NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537695 ACTIVFLO ROUTINE I-TAPED-YELLOW 1000 CASSETTES, TISSUE IDZ LEICA BIOSYSTEMS RICHMOND INC. ACTIVFLO ROUTINE I-TAPED-YELLOW 1000 20240716 20849832022446

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown