BEUDAMED
    FDA Adverse Event Summary report: N

    THINPREP 5000 AUTOLOADER READY

    MDR report key: 4101499 · Received August 27, 2014

    Report

    Report Number
    1222780-2014-00143
    Date Received
    August 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 4, 2014
    Manufacturer
    HOLOGIC INC.
    Product Code
    MKQ
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED (2) INSTANCES OF THEIR THINPREP 5000 INSTRUMENT PRODUCING AN ERROR AND STOPPING AFTER SIPPING LIQUID INTO THE FILTER. CUSTOMER WILL RECALL THE PATIENT FOR A NEW SAMPLE COLLECTION SINCE THE WHOLE SAMPLE WAS LOST. THE FIELD SERVICE ENGINEER CONFIRMED; BUT WAS UNABLE TO REPRODUCE ERROR. REPLACED PARTED AS A PRECAUTIONARY MEASURE. PERFORMED PREVENTIVE MAINTENANCE AND PERFORMED ALL REQUIRED SETUPS PER TECHNICAL DOCUMENTATION. PROCESSED SAMPLES TO CONFIRM OPERATION. INSTRUMENT OPERATIONAL. US: THIS IS A REPORTABLE EVENT SINCE THE PATIENT NEEDED TO BE RECALLED FOR ADDITIONAL SAMPLE COLLECTION, WHICH RESULTED IN A DELAY IN PATIENT DIAGNOSIS. GREAT BRITAIN: THIS IS NOT CLASSIFIED AS A REPORTABLE EVENT, PER THE CURRENT VERSION OF THE EU MEDDEV GUIDELINES. THERE WAS NO INJURY OR MISDIAGNOSIS. THE INSTRUMENT'S PROTECTION AGAINST A TECHNICAL FAULT FUNCTIONED CORRECTLY AS THE INSTRUMENT DISPLAYED AN ERROR CODE TO WARN THE USER AT THE TIME AND SUBSEQUENTLY STOPPED. THE ISSUE WAS SUCCESSFULLY RESOLVED FOLLOWING FIELD SERVICE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522690 THINPREP 5000 AUTOLOADER READY THINPREP 5000 PROCESSOR MKQ HOLOGIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other