BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCESSOR, TISSUE, AUTOMATED

    MDR report key: 19123912 · Received April 17, 2024

    Report

    Report Number
    8010478-2024-00010
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    March 15, 2024
    Report Date
    August 1, 2024
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    UDI-DI
    04049188217769
    Removal / Correction Number
    Z-1947-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO AN INVESTIGATION REPORT ISSUED ON (B)(6) 2024: AFTER EVALUATION OF THE INFORMATION AVAILABLE, IT WAS FOUND THAT THE ROOT CAUSE OF THE ISSUE WAS THAT THE OVERFILLED REAGENT BOTTLES, COMBINED WITH THE DESIGN OF THE AIR MANIFOLD, CAUSED REAGENT CROSS-CONTAMINATION. THIS CROSS-CONTAMINATION IN TURN NEGATIVELY IMPACTED THE TISSUE QUALITY. THE ROOT CAUSE THAT HAS BEEN DETERMINED FOR THIS INCIDENT IS IDENTICAL TO THE ROOT CAUSE WHICH TRIGGERED THE ONGOING FIELD SAFETY CORRECTIVE ACTION FOR THE HISTOCORE PEGASUS AND HISTOCORE PEGASUS PLUS. AFTER REPLACEMENT OF THE AIR MANIFOLD WITH A RE-DESIGNED VERSION OF THE AIR MANIFOLD AND ASSOCIATED MANIFOLD TUBES, REPLACEMENT OF THE CONDENSATE BOTTLE AND THE RETORT FILTER, THE DEVICE WAS RETURNED TO FULL FUNCTIONALITY. ON JULY 30TH, 2024, LEICA BIOSYSTEMS RECIEVED THE INFORMATION THAT NO MEDICAL TREATMENT WAS NECESSARY, AND ALL PATIENT SAMPLES WERE ABLE TO BE DIAGNOSED.

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2024 LEICA BIOSYSTEMS RECEIVED A COMPLAINT ABOUT BAD SAMPLE QUALITY OF TISSUES PROCESSED ON A HISTOCORE PEGASUS PLUS TISSUE PROCESSOR. THE TISSUE SAMPLES HAD BEEN PROCESSED OVER NIGHT ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232485 PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS PLUS 04049188217769

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown