BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOCORE SPECTRA CV

    MDR report key: 21147756 · Received January 14, 2025

    Report

    Report Number
    8010478-2025-00019
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 12, 2024
    Report Date
    March 19, 2025
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    KIM
    UDI-DI
    04049188203953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED THAT THIS INCIDENT WAS RELATED DUE TO AN ADJUSTMENT ISSUE. THE ROOT CAUSE WAS, THAT THE COVERSLIP LINE 2 WAS NOT FUNCTIONING CORRECTLY. THE FIELD SERVICE ENGINEER DETECTED A THAT THE SHIFTER TONGUE OF THE COVERSLIP LINE WAS A LITTLE BIT BENT AND THEREFORE UNDER THE SHIFTER PARTS OF A BROKEN SLIDE. THE FIELD SERVICE ENGINEER REMOVED THE DEBRIS AND ADJUSTED SHIFTER TONGUE OF THE COVERSLIP LINE. THE PERFORMANCE TEST WAS CONDUCTED AS PER INSTRUCTIONS FROM THE SERVICE MANUAL AND THE INSTRUMENT IS UP AND RUNNING ACCORDING TO THE SPECIFICATION. THE CUSTOMER ACCEPTED THE INSTRUMENT FOR THE ROUTINE USAGE. SINCE THE REPAIR HAS BEEN CARRIED OUT LEICA BIOSYSTEMS NUSSLOCH GMBH HAS NOT BEEN MADE AWARE BY THE CUSTOMER OF ANY FURTHER ISSUES WITH THIS INSTRUMENT RELATED TO THE INCIDENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2024 LEICA BIOSYSTEMS RECEIVED THE CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE SPECTRA CV, MICROSCOPE SLIDE COVERSLIPPER. AS A RESULT, THE SAMPLES WERE DAMAGED, BUT NO NEW REBIOPSY WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013239 HISTOCORE SPECTRA CV MICROSCOPE SLIDE COVERSLIPPER IVD KIM LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE SPECTRA CV 04049188203953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other