BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE (E170)

    MDR report key: 3031390 · Received April 2, 2013

    Report

    Report Number
    1823260-2013-01991
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE CREATININE JAFFE RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 3.86 MG/DL WITH A DATA FLAG AND WAS REPORTED TO THE PATIENT. ON THE FOLLOWING DAY, THE PHYSICIAN CALLED THE LAB ASKING ABOUT THE RESULT AS THE PATIENT DID NOT HAVE ANY CLINICAL EVIDENCE OF PROBLEMS. THE LAB REPEATED THE SAME SAMPLE ON (B)(6) 2013 AND THE RESULT WAS 1.05 MG/DL. NO ADVERSE EVENT WAS REPORTED. THE CREATININE R1 REAGENT LOT FOR THE INITIAL RESULT WAS 667844. THE CREATININE R1 REAGENT LOT FOR THE REPEAT RESULT WAS 663057. THE EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THE RINSE STATION TUBES WERE DIRTY AND PARTIALLY BLOCKED AT POSITIONS 8 AND 1. HE CLEANED THE RINSE STATION TUBES AND THE CUSTOMER PERFORMED CELL WASH AND CELL BLANK. THE CUSTOMER ALSO ADJUSTED THE Z MOVEMENT OF THE SAMPLE PROBE AND PERFORMED A PRECISION TEST WHICH WAS SUCCESSFUL. AS PART OF THE INVESTIGATION, THE PLOTTED KINETICS OF BOTH CREATININE RESULTS WERE REVIEWED. IT WAS DETERMINED IRREGULARITIES FOR THE HIGH RESULT WERE INDICATED AND IT SEEMED THAT SOMETHING DROPPED INTO THE CUVETTE. IT WAS DETERMINED THE ISSUE WAS SOLVED BY SERVICE ACTIONS PERFORMED BY THE FIELD SERVICE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134181 ANALYTICAL E MODULE (E170) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 021 YR FINASTERIDA