BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVFLO ROUTINE I-TAPED-YELLOW 1000

    MDR report key: 22572837 · Received July 22, 2025

    Report

    Report Number
    1419341-2025-00031
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 23, 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 26 JUN 2024 TO 26 JUN 2025 REPORTED ONE (1) OTHER RELATED OCCURRENCE OF THIS ISSUE FOR THIS PRODUCT LOT. THE PRODUCT HISTORY WAS REVIEWED AND DID NOT IDENTIFY INFORMATION IN THE MANUFACTURING RECORD FOR THIS PRODUCT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PROBLEM REPORTED IN THIS COMPLAINT. MANUFACTURER TESTING OF RETAIN SAMPLES WAS UNABLE TO REPLICATE THE "YELLOW CASSETTES AREN¿T STAYING CLOSED" REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "YELLOW CASSETTES AREN¿T STAYING CLOSED" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 23 JUNE 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "YELLOW CASSETTES AREN¿T STAYING CLOSED. THEY KEEP POPPING OPEN ON THEM. ABOUT 15% OF THE CASSETTES ARE HAVING ISSUES." 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
    1938419 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