BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREPSTAIN SYSTEM

    MDR report key: 1635534 · Received March 17, 2010

    Report

    Report Number
    1062336-2010-00002
    Event Type
    Other
    Date Received
    March 17, 2010
    Date of Event
    February 12, 2010
    Report Date
    March 17, 2010
    Manufacturer
    TRIPATH IMAGING
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT IN QUESTION (JOUAN CENTRIFUGE) WAS INSTALLED AT THE ACCOUNT AT THE END OF (B)(4) 2009. THIS IS THE FIRST TIME THE ACCOUNT HAS EXPERIENCED PROBLEMS. THE TECHNICAL SUPPORT REPRESENTATIVE ASKED THE CONTACT TO REVIEW THE CENTRIFUGE PROGRAM. PROGRAM 1 WAS INCORRECT AND WAS SET TO 500 RPMS INSTEAD OF 1080 RPMS OR 200 G. PROGRAMS 2-4 WERE SET CORRECTLY FOR TIME AND SPEED. ONLY PROGRAM 1 AND 2 ARE REQUIRED FOR PREPARING CYTOLOGICAL SPECIMENS FOR PRESTAIN PROCESSING. PROGRAM 1 IS AN IMPORTANT STEP IN SAMPLE PROCESSING AS THE MAIN PURPOSE IS TO PERFORM A SOFT SPIN THAT PULLS THE CELL SAMPLE THROUGH A DENSITY GRADIENT ENRICHING THE CLINICAL CELLS OF INTEREST AT THE BOTTOM OF THE GRADIENT AND TRAPPING DEBRIS AND PARTICLES FROM THE CELL SAMPLE AT THE TOP OF THE GRADIENT. AFTER THIS SPIN, THE SUPERNATANT IS DRAWN OFF AND PROGRAM 2 IS USED AS A HARD SPIN TO CONCENTRATE THE CELLS IN THE BOTTOM OF THE CENTRIFUGE TUBE INTO A PELLET. IT IS A CONCERN THAT OPERATION OF PROGRAM 1 AT HALF SPEED MIGHT NOT PULL AS MANY DIAGNOSTIC CELLS OF INTEREST THROUGH THE GRADIENT THUS TRAPPING AND DISCARDING CLINICALLY RELEVANT CELLS. UPON REPROGRAMMING OF THE CENTRIFUGE, THE UNSATISFACTORY RATE WAS IMPROVED TO THE POINT THAT THE ACCOUNT HAD NO FURTHER CONCERN. IT IS UNCLEAR HOW PROGRAM 1 BECAME INCORRECT. AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. THE MANUFACTURING RECORD (WHICH INCLUDES PROGRAMMING) FOR THIS SERIAL NUMBER WAS REVIEWED BY QA AND THE RECORD INDICATES THAT PROGRAMS WERE CORRECT AND CENTRIFUGE FUNCTIONED PROPERLY PRIOR TO BEING SHIPPED. THE CENTRIFUGE WAS NOT INSTALLED OR VERIFIED BY TRIPATH PERSONNEL. IT IS POSSIBLE FOR THE USER TO CHANGE THE PROGRAMS. A JOUAN OPERATOR'S MANUAL IS SENT WITH EACH JOUAN CENTRIFUGE.

    Description of Event or Problem · 1

    THE CYTOPATHOLOGY LABORATORY OBSERVED THAT THEIR UNSATISFACTORY RATE (TOO FEW CELLS ON THE SLIDE FOR EVALUATION) FOR SUREPATH PAP TEST HAD INCREASED IN THE LAST FEW WEEKS. THE ACCOUNT DEFINES AN UNSATISFACTORY AS <5000 CELLS PER SLIDE WHICH IS CONSISTENT WITH THE PREPSTAIN LABELING. THEY HAD 5 UNSATISFACTORY SAMPLES IN ONE WEEK FROM DIFFERENT COLLECTION SITES. THE CYTOLOGY SUPERVISOR FELT THAT THERE MAY BE SOMETHING DIFFERENT ABOUT THE PROCESS THAT WAS CAUSING THE HIGHER THAN TYPICAL UNSATISFACTORY RATE. A PATIENT IS OFTEN CALLED BACK TO THE PHYSICIAN'S OFFICE TO REPEAT THE PAP TEST IF THE FIRST SAMPLE IS UNSATISFACTORY. THERE IS NO HEALTH RISK IN RECOLLECTION OF A PAP SAMPLE JUST A DELAY IN FINAL REPORTING OF RESULTS. THERE IS ALSO THE POTENTIAL FOR A MISSED POSITIVE RESULT IF THE PATIENT DID NOT RETURN FOR A SECOND TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPSTAIN SYSTEM JOUAN CENTRIFUGE (COMPONENT) MKQ TRIPATH IMAGING JOUAN C4I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other