BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1371887 · Received February 16, 2009

    Report

    Report Number
    1823260-2009-01231
    Event Type
    Malfunction
    Date Received
    February 16, 2009
    Date of Event
    January 25, 2009
    Report Date
    February 16, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP DETERMINED THE ISE MIXING TOWER WAS CLOGGED. HE REPLACED THE MIXING TOWER, INSTRUCTED THEM ON PROPER MIXING TOWER CLEANING. HE CALIBRATED THE ISE TESTS IN DIAGNOSTICS AND USER SOFTWARE, RAN CONTROLS, AND RAN PRECISION CHECKS. SAMPLES WERE RETESTED AND RAN COMPARABLY WITH THE OTHER ANALYZER.

    Description of Event or Problem · 1

    USER STATES THAT THEY ARE HAVING DISCREPANCIES IN SODIUM RESULTS. USER STATES THAT THERE WERE 4 PTS INVOLVED. NONE OF THE RESULTS FROM THIS ANALYZER WERE REPORTED. SAMPLE 1 OCCURRED IN 2009, RESULTS FROM THIS ANALYZER WERE 132, 133 AND 135 MMOL PER L, AND RESULT FROM OTHER ANALYZER WAS 139 MMOL PER L. ON 2 DAYS LATER, SAMPLE 2: RESULT FROM THIS ANALYZER WAS 123 MMOL PER L, REPEAT RESULTS FROM THE OTHER ANALYZER WERE 128 AND 129 MMOL PER L. SAMPLE 3: RESULT FROM THIS ANALYZER WAS 134 MMOL PER L, REPEAT RESULT FROM THE OTHER ANALYZER WAS 141 MMOL PER L.

    Additional Manufacturer Narrative · 2

    THE FIELD SERVICE REP DETERMINED THE ISE MIXING TOWER WAS CLOGGED. HE REPLACED THE MIXING TOWER, INSTRUCTED THEM ON PROPER MIXING TOWER CLEANING. HE CALIBRATED THE ISE TESTS IN DIAGNOSTICS AND USER SOFTWARE, RAN CONTROLS, AND RAN PRECISION CHECKS. SAMPLES WERE RETESTED AND RAN COMPARABLY WITH THE OTHER ANALYZER.

    Description of Event or Problem · 2

    USER STATES THAT THEY ARE HAVING DISCREPANCIES IN SODIUM RESULTS. USER STATES THAT THERE WERE 4 PTS INVOLVED. NONE OF THE RESULTS FROM THIS ANALYZER WERE REPORTED. SAMPLE 4: RESULT FROM THIS ANALYZER WAS 131 MMOL PER L, REPEAT RESULT FROM THE OTHER ANALYZER WAS 137 MMOL PER L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1
    2 62 YR