BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1432950 · Received May 15, 2009

    Report

    Report Number
    1823260-2009-03481
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    April 24, 2009
    Report Date
    May 15, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE AND NOTED, HE CHECKED THE SAMPLE AND FOUND IT TO BE CLEAR. HE PERFORMED A CHECK TEST WITH HIGH RESULTS AND REPLACED THE ST2 PROBE TO CORRECT THIS. QC AND PATIENT SAMPLES WERE PERFORMED TO VERIFY THE ANALYZER PERFORMANCE.

    Description of Event or Problem · 1

    THE USER RECEIVED AN ERRONEOUS ALP RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 139 U PER L, REPEAT RESULTS WERE 118 AN 275 U PER L. THE USER THEN RAN THE SAMPLE IN A MICROCUP FIVE TIMES TO CHECK THE ALP PRECISION WITH THE FOLLOWING RESULTS: 119, 120, 119, 119 AND 116 U PER L. ALL TESTING WAS PERFORMED ON THE SAME DAY FROM THE SAME SAMPLE TUBE. THE USER STATED THEY THEN SENT THE SAMPLE OUT AND IT RECOVERED 119 U PER L SEVERAL TIMES, AND THIS RESULT WAS REPORTED. PATIENT NOT ADVERSELY AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK