BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1917285 · Received December 8, 2010

    Report

    Report Number
    1823260-2010-07253
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 8, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER RECEIVED QUESTIONABLE SODIUM RESULTS FOR TWO PATIENT SAMPLES. PATIENT SAMPLE 1 INITIAL RESULT WAS 127 MMOL/L AND THE REPEAT RESULT WAS 135 MMOL/L. PATIENT SAMPLE 2 WAS TESTED ON (B)(6) 2010. THE INITIAL RESULT WAS 133 MMOL/L AND THE REPEAT RESULTS WERE 141, 139, 139 AND 139 MMOL/L. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE RESULT OF 135 MMOL/L WAS REPORTED FOR PATIENT SAMPLE 1 AND A RESULT OF 139 MMOL/L WAS REPORTED FOR PATIENT SAMPLE 2. THE LOT NUMBER OF THE SODIUM ELECTRODE WAS 21502437. THE USER DECLINED A SERVICE VISIT. THE USER STATED THEY REPLACED THE SAMPLE PROBE AND FELT THIS MAY ADDRESS THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1