BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1061919 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04734
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PTS WITH DISCREPANT PHOSPHORUS OR CREATININE RESULTS. PT 1, 2008, INITIAL PHOSPHORUS RESULT 2.64 MMOL/L, REPEATED TWICE, 2008, GAVE 0.98 MMOL/L AND 0.99 MMOL/L. INITIAL RESULTS WERE REPORTED, PTS WERE NOT ADVERSELY AFFECTED. THE INVESTIGATIONAL UNIT WAS UNABLE TO DETERMINE ROOT CAUSE BUT STATED THE FIELD SERVICE REP REPLACED THE SAMPLE SYRINGES AND PROBES THAT RESOLVED THE ISSUE. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 2

    TWO PATIENTS WITH DISCREPANT PHOSPHORUS OR CREATININE RESULTS. PT 2, FEMALE, BORN 2008, HAD TWO SAMPLES WITH DISCREPANT CREATINE RESULTS: FIRST SAMPLE, 2008, INITIAL RESULT 51 UMOL/L, REPEATED TWICE GAVE 92.5 AND 103 UMOL/L; SECOND SAMPLE, 2008, INITIAL RESULT 208 UMOL/L, REPEATED TWICE GAVE 40.3 AND 41.2 UMOL/L. INITIAL RESULTS WERE REPORTED, PTS WERE NOT ADVERSELY AFFECTED. THE INVESTIGATIONAL UNIT WAS UNABLE TO DETERMINE ROOT CAUSE BUT STATED THE FIELD SERVICE REP REPLACED THE SAMPLE SYRINGES AND PROBES THAT RESOLVED THE ISSUE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER-JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK
    2 2 DA