BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASP6025

    MDR report key: 7116384 · Received December 14, 2017

    Report

    Report Number
    8010478-2017-00009
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 20, 2017
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED THE FOLLOWING: THE INCIDENT WAS PRESUMABLY USER RELATED DUE TO A WRONG APPLICATION FROM THE CUSTOMER SITE. THE UNIT HAS BEEN INVESTIGATED BY A LEICA PRODUCT SPECIALIST FROM SERVICE SUPPORT. THE ANALYSIS OF THE INSTRUMENT REVEALED THAT THERE WAS NO TECHNICAL FAILURE OF THE DEVICE FOUND WHICH WOULD HAVE LED TO NON-DIAGNOSABLE TISSUES. THE ANALYSIS SHOWED THAT THE THRESHOLDS OF THE REAGENTS WERE EXCEEDED, AND THAT THE REAGENTS SHOULD HAVE HAD BEEN REPLACED EARLIER. THIS CAUSED THE SUBOPTIMAL PROCESSED TISSUES. A CUSTOMER FACING LETTER WAS SENT TO THE CUSTOMER WITH A RECOMMENDATION IN THE FUTURE OF HOW TO PROPERLY CARE FOR THE TISSUES, AND THE ADJUSTMENT OF THE THRESHOLD VALUES DURING THE PROCESSING WITH THE TISSUE PROCESSOR. SECTION SERIAL # OF THE INITIAL 30-DAY FDA 3500A REPORT CONTAINED THE INCORRECT SERIAL NUMBER. THE CORRECT SERIAL NUMBER, (B)(4), HAS BEEN INCLUDED IN THIS FOLLOW UP #1 REPORT TO REFLECT THIS UPDATE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE EVENT IS CURRENTLY UNDERWAY AND IT WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2017 THEY EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR ASP6025. AS A RESULT FOR AROUND 100 SMALL SAMPLES WERE UNDIAGNOSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898063 ASP6025 ASP6025 IEO LEICA BIOSYSTEMS NUSSLOCH GMBH 14049543267

    Patients

    Seq Age Sex Outcome Treatment
    1 Other