BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINPREP 5000 PROCESSOR

    MDR report key: 6159239 · Received December 9, 2016

    Report

    Report Number
    1222780-2016-00269
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Report Date
    November 11, 2016
    Manufacturer
    HOLOGIC, INC
    Product Code
    MKQ
    PMA / PMN Number
    950039/S26
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOLOGIC'S FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND CONFIRMED 6007/SE026 AND REPRODUCED ERROR. THE FSE FOUND THE MOST LIKELY CAUSE OF THE ERROR SLIDE ROTATOR FLAG CRASHING WITH HOME SENSOR. THE FSE ADJUSTED SLIDE ROTATOR TO SOLVE THE ISSUE. THE FSE ALSO PERFORMED WIZARD FOR SLIDE HANDOFF TO SCARA AND WIZARD FOR CAROUSEL SLIDE/VIAL/FILTER, AS THE INSTRUMENT NEED. THE FSE RAN ALL NON-INTERACTIVE TESTS TO VERIFY INSTRUMENT OPERATION. PROCESSED SAMPLES TO CONFIRM OPERATION (AROUND 250). INSTRUMENT OPERATIONAL. INTERNAL REFERENCE COMPLAINT: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2016, THE CUSTOMER WAS RUNNING A BATCH OVERNIGHT AND THE SLIDES WERE LEFT OUTSIDE THE FIXATIVE BATH. THE FOLLOWING DAY THE CUSTOMER SAW A SYSTEM ERROR CODE 6007-SE026 AND ALSO 6513-CO547 ON ASSY AUTOLOADER READY T5000. THE PATIENT NEEDED TO BE RECALLED. HOLOGIC'S FIELD SERVICE ENGINEER (FSE) CALLED TO ATTEND SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815278 THINPREP 5000 PROCESSOR THINPREP 5000 PROCESSOR MKQ HOLOGIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1