BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 SYSTEM

    MDR report key: 2982355 · Received February 28, 2013

    Report

    Report Number
    1823260-2013-01204
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBC
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE (PROBNP) RESULT FOR ONE PATIENT ON THEIR E411 ANALYZER. THE PATIENT'S INITIAL PROBNP RESULT WAS LESS THAN 5.0 PG/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER QUESTIONED THE INITIAL RESULT. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE CHECKED THE ANALYZER AND THE QUALITY CONTROL FOR ALL PARAMETERS AND THEY WERE OK. HE CHECKED THE LEVEL 2 QUALITY CONTROL RESULTS OF PROBNP AND THEY WERE OK. HE PREPARED AND RAN LEVEL 1 QUALITY CONTROL AND THE RESULTS WERE NOT WITHIN RANGE AND LOW. HE CHECKED THE CALIBRATION RESULTS AND THEY WERE NOT ACCURATE. HE PREPARED FRESH CALIBRATOR AND RE-CALIBRATED. THE CALIBRATION SIGNALS WERE ACCURATE. AFTER CALIBRATION, LEVEL 1 QUALITY CONTROL WAS RUN AND WITHIN RANGE. THE PATIENT'S SAMPLE WAS THEN REPEATED AND THE RESULT WAS 660 PG/ML. THE LABORATORY INFORMED THE CONCERNED PERSONS ABOUT THE NEW RESULT AND THERE WERE NO ADVERSE EVENTS. THE PROBNP REAGENT LOT NUMBER WAS 16845205 AND THE EXPIRATION DATE WAS 09/29/2013. THE PATIENT'S LOW PROBNP RESULT WAS POSSIBLY DUE TO THE INCORRECT CALIBRATION, WHICH IS ALSO INDICATED BY THE INCORRECT LEVEL 1 QUALITY CONTROL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85752 COBAS E411 SYSTEM IMMUNOCHEMISTRY ANALYZER NBC ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1