BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCESSOR, TISSUE, AUTOMATED

    MDR report key: 19069646 · Received April 9, 2024

    Report

    Report Number
    8010478-2024-00009
    Event Type
    Injury
    Date Received
    April 9, 2024
    Report Date
    August 1, 2024
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    UDI-DI
    04049188217769
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 23 JULY 2024: THE LEICA BIOSYSTEMS CUSTOMER SUPPORT DEPARTMENT CONFIRMED THAT, AS PER FEEDBACK FROM THE CUSTOMER: NOT ALL SAMPLES WERE DIAGNOSABLE, BUT THAT SINCE THERE WERE MULTIPLE SAMPLES PER PATIENT, THERE WAS NO DELAY IN DIAGNOSIS AND NO RE-BIOPSY NECESSARY. AFTER EVALUATION OF THE INFORMATION AVAILABLE, IT WAS FOUND THAT THE ROOT CAUSE OF THE ISSUE WAS USER RELATED. THE INCORRECT THRESHOLD SETTINGS WERE USED, AND THE REAGENT ALCOHOLS WERE FOUND TO BE CONTAMINATED DUE TO INFREQUENT REAGENT CHANGES. AFTER REPLACEMENT OF THE CONTAMINATED REAGENT ALCOHOLS, AND SETTING OF THE CORRECT THRESHOLD LEVELS, THE INSTRUMENT WAS WORKING ACCORDING TO FACTORY SPECIFICATIONS. THE RESPONSIBLE LEICA BIOSYSTEMS FIELD SERVICE ENGINEER CARRIED OUT ADDITIONAL TRAINING MEASURES AT THE CUSTOMER SITE, HIGHLIGHTING THE IMPORTANCE OF MAINTAINING A GOOD ETHANOL GRADIENT DURING THE REAGENT EXCHANGE PROCESS. THE INSTRUMENT HAS BEEN RETURNED TO CLINICAL USE AND THE CUSTOMER HAS CONFIRMED THAT NO MORE PROCESSING ISSUES HAVE BEEN OBSERVED.

    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 11 MARCH 2024 LEICA BIOSYSTEMS RECEIVED A COMPLAINT ABOUT A DENSITOMETER ERROR OF THE HISTOCORE PEGASUS PLUS, TISSUE PROCESSOR. ON 25 MARCH 2024 FURTHER INFORMATION WAS RECEIVED THAT SAMPLES THAT HAD BEEN PROCESSED ON THE TISSUE PROCESSOR ON (B)(6) 2024, (B)(6) 2024 AND (B)(6) 2024 WERE NEGATIVELY IMPACTED AND HAD A BURNT APPEARANCE UNDER THE MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513574 PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS PLUS 04049188217769

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown