BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PREPSTAIN

    MDR report key: 3050262 · Received April 5, 2013

    Report

    Report Number
    1062336-2013-00005
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    MNM
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN THE HEALTH OF A PATIENT OR USER; HOWEVER, INFORMATION DOES SUGGEST THAT IF THE DEVICE MALFUNCTION WERE TO RECUR, IT WOULD CONTRIBUTE TO AN INCORRECT DIAGNOSIS. A TOTAL OF 258 PATIENT SAMPLES WERE IMPACTED. ALL SAMPLES WERE RE-TESTED RESULTING IN ONE AMENDED REPORT FOR A (B)(6). A BD FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. BD CONFIRMED THE TUBE RACK SETTINGS ON RACK 4 ONLY WAS INCORRECT DUE TO HUMAN ERROR. THE PREPSTAIN RACK SETTINGS WERE CORRECTED AND THE SYSTEM WAS VERIFIED AS OPERATIONAL. BD INVESTIGATION (B)(4) WAS OPENED TO IDENTIFY ROOT CAUSE AND CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED TECHNICAL SUPPORT VIA TELEPHONE THAT THE PREPSTAIN AG WAS NOT PROPERLY TRANSFERRING SPECIMENS. THE INITIAL COMPLAINT ((B)(4)) NOTED, "(B)(6), CT SUPERVISOR, HAD A CT REPORT TO HER THAT SHE NOTICED A PATTERN OF 3 SETS OF 4 SLIDES IN A ROW THAT WERE IDENTICAL ABOUT A WEEK AGO. THIS WAS THE 4TH TRAY ON A RUN OF 48. SLIDES 1, 2, 3, 4 WERE THE SAME CASE FROM CENTRIFUGE TUBE 1. SLIDES 5, 6, 7, 8 WERE THE SAME CASE FROM TUBE 5. SLIDES 9, 10, 11, 12 WERE THE SAME CASE FROM CENTRIFUGE TUBE 9. THE FIRST 3 TRAYS ON THE SAME RUN WERE FINE. THEY REPROCESSED THESE 12 CASES FROM TRAY 4 AND WHILE CASES 1, 5 AND 9 MATCHED THE FIRST RUN, ALL OTHER CASES WERE DIFFERENT. THEY REVIEWED SEVERAL RUNS BEFORE AND AFTER THIS INCIDENT AND DID NOT FIND THIS SITUATION DUPLICATED BUT ARE CONCERNED AND WOULD LIKE THE INSTRUMENT CHECKED OUT." THE CUSTOMER FOLLOWED UP VIA TELEPHONE THE SAME DAY IN CALL (B)(6) INDICATING "THAT UPON FURTHER TESTING THEY HAVE OBSERVED THE INSTRUMENT ON A TEST RUN AND THAT TRAY 4 IS REPRODUCIBLY MISS TRANSFERRING SPECIMENS. BASED ON THIS IT HAS BEEN 6 DAYS THAT THEY KNOW OF THAT THIS INSTRUMENT HAS BEEN MISS TRANSFERRING SPECIMENS. THEY RUN 5-11 RUNS PER DAY ON THIS INSTRUMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141943 BD PREPSTAIN PREPSTAIN AG MNM TRIPATH IMAGING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1