BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2018-00453

    MDR report key: 7273535 · Received February 15, 2018

    Report

    Report Number
    1823260-2018-00453
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 26, 2018
    Report Date
    February 15, 2018
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED AN ISSUE OVER SEVERAL DAYS WHERE THE ELECSYS FREE PSA IMMUNOASSAY WOULD BE ORDERED IN THE COBAS E 411 IMMUNOASSAY ANALYZER SOFTWARE FOR PATIENT SAMPLES AND QC MATERIAL WHERE THE TEST HAD NOT BEEN REQUESTED AND THE RESULT FOR FREE PSA WAS IDENTICAL FOR ALL PATIENT SAMPLES. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. OPERATIONAL AND MECHANICAL CHECKS WERE ACCEPTABLE. THE CUSTOMER POWERED DOWN AND REBOOTED THE ANALYZER MULTIPLE TIMES. THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) WAS ALSO RESTARTED. THE INSTRUMENT WAS THEN RUNNING AS EXPECTED AND THE PROBLEM SEEMED TO BE RESOLVED. ON (B)(6) 2018, THE CUSTOMER REPEATED ALL OF THE PATIENT SAMPLES. TWO EXAMPLES WERE PROVIDED. PATIENT 1 ORIGINAL RESULT WAS 39.98 NG/ML AND THE REPEAT RESULT WAS 1.87 NG/ML. PATIENT 2 ORIGINAL RESULT WAS 39.98 NG/ML AND THE REPEAT RESULT WAS 0.488 NG/ML. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. NO PATIENTS WERE ADVERSELY AFFECTED. THE FREE PSA REAGENT LOT NUMBER WAS 243142. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION CONFIRMED THE SOFTWARE ISSUE WHICH HAS BEEN CORRECTED IN A NEW SOFTWARE VERSION.

    Patients

    Seq Age Sex Outcome Treatment
    1