BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 1630812 · Received March 8, 2010

    Report

    Report Number
    MW5015111
    Event Type
    Other
    Date Received
    March 8, 2010
    Date of Event
    October 1, 2008
    Report Date
    March 8, 2010
    Manufacturer
    NA
    Product Code
    LTJ
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2008, TESTING FOR FREE PSA WAS BEGUN AT THE (B) (6). DATE ERROR IDENTIFIED: (B) (6) 2010. PHYSICIAN NOTIFIED LAB OF INCORRECT PERCENT RISK INTERPRETATION. DATE ERROR CORRECTED: 01/27/10. THE CALCULATION WAS MODIFIED TO USE THE CORRECT TEST RESULTS TO DETERMINE THE INTERPRETATION. OVER THE PERIOD FROM (B) (6) 2008 UNTIL (B) (6) 2010, OF A TOTAL OF 980 FREE PSA ORDERS THAT HAD INTERPRETATIONS PROVIDED - THOSE WITH TOTAL PSA'S IN THE 2.0-10.0 RANGE-, 288 REPORTS WERE IDENTIFIED THAT INCLUDED INCORRECTLY CALCULATED INTERPRETATIONS. INCORRECT 'PERCENT RISK CALCULATION' REPORTED ON 288 PATIENT'S. THE CALCULATION TO FILL IN THE INTERPRETATION VALUE WAS BUILT BY (B) (6) IN THE (B) (6) TEST AREA AND VALIDATED BY THE LAB STAFF. IT IS NOT POSSIBLE TO COPY MAINTENANCE DEFINITIONS FROM (B) (6) TEST AREA TO (B) (6) LIVE AREA. ALL DEFINITIONS HAVE TO BE RE-KEYED INTO THE LIVE AREA. WHEN THE CALCULATION DEFINITIONS WERE KEYED INTO (B) (6) LIVE AREA BY (B) (6), INSTEAD OF USING THE FTRPSA TEST -RATIO- TO DETERMINE THE RESULT OF THE INTERPRETATION, THE FRPSA -PSA, FREE- TEST CODE WAS USED. THE CALCULATION WAS VERIFIED AS IT WAS DEFINED BY THE LAB STAFF IN (B) (6) LIVE, BUT THE INCORRECT TEST CODE USED IN THE CALCULATION IN LIVE WAS NOT NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA LTJ NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1