BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREPSTAIN SLIDE PROCESSOR

    MDR report key: 1635448 · Received March 17, 2010

    Report

    Report Number
    1062336-2010-00003
    Event Type
    Injury
    Date Received
    March 17, 2010
    Date of Event
    February 8, 2010
    Report Date
    March 17, 2010
    Manufacturer
    TRIPATH IMAGING
    Product Code
    KPA
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THEY UTILIZE THE SAME EQUIPMENT, THE NON-GYNECOLOGICAL APPLICATION IS NOT INCLUDED PMA P970018 FOR THE PREPSTAIN SLIDE PROCESSOR. VERIFIED CUSTOMER IS USING SOFTWARE VERSIONS (B) (4) AND UTILITY SOFTWARE (B) (4). THIS SOFTWARE WAS NOT PART OF ANY PREVIOUS FIELD ACTIONS OR RECALLS. OF THE 6 NON-GYNECOLOGICAL SAMPLES PROCESSED THAT DAY, THREE SAMPLES WERE FOUND TO BE MIX-MATCHED; HOWEVER, ONLY ONE RESULTED IN AN ADVERSE PT OUTCOME. TRAY 1 CASE 3 SLIDE- SHOULD HAVE BEEN AN OVARIAN ADENOCARCINOMA IN AN ASCITES FLUID, BUT THE SLIDE CONTAINED BENIGN CELLS ON THE CYTOLOGY. THERE WAS A MALIGNANT CELL BLOCK AND MALIGNANT SURGICAL SPECIMEN FOR OVARIAN CANCER. THE CASE WAS REPORTED AS ADENOCARCINOMA. TRAY 1 CASE 4 SLIDE- SHOULD HAVE BEEN THE BENIGN PANCREATIC CYST FLUID, BUT THE SLIDE CONTAINED ABUNDANT ADENOCARCINOMA FROM A MALIGNANT PANCREATIC CYST FLUID. THERE WAS NOT A CELL BLOCK ON THIS CASE. THE CASE WAS REPORTED AS ADENOCARCINOMA. TRAY 1 CASE 5 SLIDE- SHOULD HAVE BEEN CELLS FROM THE ADENOCARCINOMA OF PANCREAS, BUT CONTAINED ABUNDANT CELLS FROM THE OVARIAN ADENOCARCINOMA. THERE WAS A MALIGNANT CELL BLOCK ON THIS CASE AND THE CASE WAS REPORTED AS ADENOCARCINOMA. THE THREE CASES INVOLVED WERE "WALL TO WALL CANCER" WITH NO EVIDENCE OF INCIDENTAL CONTAMINATION. ON MONDAY, (B) (6), THE LABORATORY RAN A 24-SAMPLE TEST RUN AND VERIFIED THAT TUBE 1 GOES TO SLIDE 1, TUBE 2 TO SLIDE 2, TUBE 3 TO SLIDE 3 THROUGH 24. EVERYTHING WAS DELIVERED CORRECTLY. THEY MONITORED SPECIMEN DELIVERY FOR 2 DAYS AND CONCLUDED THAT THIS IS NOT A CASE OF MACHINE CROSS CONTAMINATION. BOTH THE PREP TECH THAT PROCESSED THE SAMPLES AND THE CYTOLOGY SUPERVISOR THINK THAT THIS WAS AN OPERATOR ERROR.

    Description of Event or Problem · 1

    ON MONDAY, (B) (6) 2010, 6 NON-GYNECOLOGICAL CASES WERE PROCESSED BY A PREPARATION TECHNOLOGIST THAT DID NOT USUALLY PROCESS ON THE PREPSTAIN SLIDE PROCESSOR. THE CYTOLOGY SUPERVISOR REPORTED THAT THE DAY WAS VERY BUSY AND THE PREP TECH DID NOT VERIFY THAT THE SLIDES AND TUBES MATCHED. ON THURSDAY, (B) (6) 2010, A PT WITH A REPORTED PANCREATIC ADENOCARCINOMA PROCESSED ON (B) (6) HAD THE TAIL SECTION OF HER PANCREAS REMOVED AND PART OF HER STOMACH AND SPLEEN REMOVED AS A RESULT OF THIS DIAGNOSIS. WE DO NOT KNOW WHETHER THE SURGERY WAS DONE PRIMARILY BECAUSE OF THE CYTOLOGY RESULT. HOWEVER, THE PT UNDERWENT A SURGICAL PROCEDURE WITH EVERY EXPECTATION OF FINDING CANCER BASED UPON THE ERRONEOUS CYTOLOGY RESULT. AN OPERATION FOR A PANCREATIC CYST WOULD NOT TYPICALLY HAVE BEEN THIS EXTENSIVE. THE EXTENSIVE NATURE OF THE SURGERY IS USUALLY ONLY DONE AS PART OF A CURATIVE CANCER SURGERY. IF THAT IS THE CASE, THE MIX-UP IN THE CYTOLOGY SPECIMENS CLEARLY HAD AN ADVERSE IMPACT ON THE PT. IT DOES NOT APPEAR FROM ANY OF THE AVAILABLE INFO THAT A MALFUNCTION OF THE PREPSTAIN SYSTEM HAD ANYTHING TO DO WITH THE MIX-UP IN SPECIMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPSTAIN SLIDE PROCESSOR NONE KPA TRIPATH IMAGING TECAN AG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other