BEUDAMED
    FDA Adverse Event Summary report: N

    THINPREP 5000 PROCESSOR

    MDR report key: 5000664 · Received August 11, 2015

    Report

    Report Number
    1222780-2015-00142
    Date Received
    August 11, 2015
    Date of Event
    January 1, 2015
    Report Date
    August 11, 2015
    Manufacturer
    HOLOGIC INC.
    Product Code
    MKQ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED IN (B)(6) THAT THEIR THINPREP 5000 PROCESSOR AUTOLOADER ETCHED A WRONG ID ONTO A SLIDE. THE CUSTOMER PROCESSED THE SAMPLE A SECOND TIME AND IT PROCESSED CORRECTLY. NO PT RECALL WAS REQUIRED AS A RESULT OF THE ERROR AND NO FURTHER INSTANCES OF MISPRINTS WERE REPORTED. HOLOGIC TECHNICAL SERVICE ASKED THE CUSTOMER TO KEEP THE VIAL AND THE SLIDE FOR INVESTIGATION PURPOSES. HOLOGIC'S FIELD SERVICE ENGINEER CONFIRMED AND REPRODUCED THE ERROR. FOUND THE MOST LIKELY CAUSE OF THE ERROR BEING A POORLY PRINTED ADDITIONAL BARCODE LABEL APPLIED TO THE VIAL BY THE GENERAL PRACTITIONER BEING READ INSTEAD OF A LABORATORY APPLIED LABEL. INSTRUMENT IS OPERATIONAL. THIS IS CONSIDERED A REPORTABLE EVENT SINCE THE THINPREP 5000 PROCESSOR DID NOT PERFORM AS INTENDED AND THIS COULD POTENTIALLY LEAD TO A MISDIAGNOSIS OR DELAY IN DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525446 THINPREP 5000 PROCESSOR THINPREP 5000 PROCESSOR MKQ HOLOGIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other