BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1422487 · Received April 28, 2009

    Report

    Report Number
    1823260-2009-03006
    Event Type
    Malfunction
    Date Received
    April 28, 2009
    Date of Event
    March 31, 2009
    Report Date
    April 28, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A LOOSE LOCKING NUT ON THE RT1/SR SYRINGE AND TIGHTENED THE SYRINGE LOCK. HE PERFORMED A CHECK TEST AND ALL PARAMETERS WERE WITHIN SPECIFICATION. CALIBRATION AND QC WERE PERFORMED TO VERIFY THE OPERATION OF THE ANALYZER.

    Description of Event or Problem · 1

    THE USER STATES THAT THE FIELD SERVICE REPRESENTATIVE WAS ONSITE TO DO PREVENTIVE MAINTENANCE AND AFTER HE LEFT, THEY STARTED RUNNING PTS ON VARIOUS ASSAYS AND 74 PTS' RESULTS WERE QUESTIONABLE. THE FIELD SERVICE REPRESENTATIVE WAS DISPATCHED IN 2009, AND HE NOTICED THAT THE SYRINGE WAS LOOSE AND HAD AIR BUBBLES IN THE SYRINGE WHICH THEY THOUGHT TO BE THE CAUSE OF THE INACCURATE RESULTS. THE USER THEN RERAN QC WHICH WAS GOOD AND RERAN THE 74 PTS WITH DIFFERENT OUTCOMES THAN THE ORIGINALS. TWO PTS' RESULTS WERE CONSIDERED DISCREPANT. INITIAL VANCOMYCIN RESULT WAS 6.2 UG PER ML, REPEAT RESULT THE NEXT DAY WAS 7.7 UG PER ML. ALL 74 INITIAL RESULTS WERE REPORTED, BUT NO ADVERSE REACTION HAS OCCURRED FROM THE REPORTING OF THESE RESULTS.

    Additional Manufacturer Narrative · 2

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE LOOSE LOCKING NUT ON THE RT1/SR SYRINGE AND TIGHTENED THE SYRINGE LOCK. HE PERFORMED A CHECK TEST AND ALL PARAMETERS WERE WITHIN SPECIFICATION. CALIBRATION AND QC WERE PERFORMED TO VERIFY THE OPERATION OF THE ANALYZER.

    Description of Event or Problem · 2

    THE USER STATES THAT THE FIELD SERVICE REPRESENTATIVE WAS ONSITE TO DO PREVENTIVE MAINTENANCE AND AFTER HE LEFT THEY STARTED RUNNING PTS ON VARIOUS ASSAYS AND 74 PTS' RESULTS WERE QUESTIONABLE. THE FIELD SERVICE REPRESENTATIVE WAS DISPATCHED IN 2009, AND HE NOTICED THAT THE SYRINGE WAS LOOSE AND HAD AIR BUBBLES IN THE SYRINGE WHICH THEY THOUGHT TO BE THE CAUSE OF THE INACCURATE RESULTS. THE USER THEN RERAN QC WHICH WAS GOOD AND RERAN THE 74 PTS WITH DIFFERENT OUTCOMES THAN THE ORIGINALS. TWO PTS' RESULTS WERE CONSIDERED DISCREPANT. INITIAL VANCOMYCIN RESULT THE NEXT DAY, WAS 1.9 UG PER ML, REPEAT RESULT THE SAME DAY, WAS 4.1 UG PER ML. ALL 74 INITIAL RESULTS WERE REPORTED, BUT NO ADVERSE REACTION HAS OCCURRED FROM THE REPORTING OF THESE RESULTS.

    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 51 YR
    2 56 YR