BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1591382 · Received February 1, 2010

    Report

    Report Number
    1823260-2010-00670
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    January 7, 2010
    Report Date
    February 1, 2010
    Manufacturer
    NA
    Product Code
    LTJ
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED ONE PATIENT SAMPLE WITH AN INITIAL FREE PSA RESULT OF 0.017 NG/ML AND TOTAL PSA RESULT OF 0.76 NG/ML RUN FROM AN ALIQUOT WERE REPORTED OUT. THE PHYSICIAN QUESTIONED THE RESULTS BASED ON PREVIOUS RESULTS FOR THIS PATIENT. THE SAMPLE WAS REPEATED TWICE ON (B) (6) 2010 GIVING 1.04 AND 1.02 NG/ML RESULTS FOR FREE PSA AND 6.53 AND 6.47 NG/ML RESULTS FOR TOTAL PSA RESPECTIVELY. A DIFFERENT SAMPLE DRAWN THE SAME TIME AS THE ORIGINAL SAMPLE WAS TESTED GIVING 0.938 NG/ML RESULT FOR FREE PSA AND 6.17 NG/ML RESULT FOR TOTAL PSA. THE PATIENT WAS NOT TREATED OR ADVERSELY AFFECTED BY THE DISCREPANCY IN RESULTS. SAMPLE TYPE IS LITHIUM HEPARIN. REAGENT LOT NUMBERS: FREE PSA # 15571001. TOTAL PSA # 15391004. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE THOROUGHLY CHECKED INSTRUMENT. CUSTOMER RAN CALIBRATION, CONTROLS AND A PRECISION RUN TO VERIFY ANALYZER PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER LTJ NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1