BEUDAMED
    FDA Adverse Event Summary report: N

    THINPREP 5000 PROCESSOR

    MDR report key: 3897672 · Received June 10, 2014

    Report

    Report Number
    1222780-2014-00094
    Date Received
    June 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 19, 2014
    Manufacturer
    HOLOGIC INC.
    Product Code
    MKQ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE THINPREP 5000 PROCESSOR PRODUCED AN ERROR (SE 6006 SH 024), ALSO BROKE SOME SLIDES (BEFORE PUTTING CELLS ON THEM), AND LOST SOME SAMPLE (NON-GYN, UROCYTE). THE PATIENT WILL BE CALLED BACK. THE CUSTOMER STOPPED THE UNIT. HOLOGIC FIELD SERVICE ENGINEER CONFIRMED AND REPRODUCED ERROR (SE 6006 SH 024). FOUND THE FOLLOWING TO BE THE MOST LIKELY CAUSE OF THE ERROR: DIRTY VACUUM CUPS (CLEANED). REPLACED 3V BATTERY CR 2032 (SBC). RAN ALL NON-INTERACTIVE MOTION AND GO NO-GO TESTS TO VERIFY INSTRUMENT OPERATION. PROCESSED SAMPLES TO CONFIRM OPERATION. INSTRUMENT OPERATIONAL. SPAIN: THIS IS NOT CLASSIFIED AS A REPORTABLE EVENT SINCE THIS IS A TECHNICAL ISSUE. THE INSTRUMENT ISSUED A WARNING/ERROR CODE, WHICH ALERTED THE USER. THE DISPATCHED ENGINEER WAS ABLE TO CONFIRM AND REPRODUCE THAT ERROR AND RESOLVED THE ISSUE BY TECHNICAL/SERVICE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343421 THINPREP 5000 PROCESSOR THINPREP 5000 PROCESSOR MKQ HOLOGIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other