BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS INTEGRA 800

    MDR report key: 2002868 · Received February 28, 2011

    Report

    Report Number
    1823260-2011-01061
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    January 29, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DAP
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED UPON INFORMATION PROVIDED, THE RERUN OF THE PATIENT'S FIRST BLOOD SAMPLE TAKEN ON (B)(6) 2011 CONFIRMED AN ELEVATED D-DIMER RESULT. THE REACTION CURVE FROM THE SECONDARY TUBE FROM (B)(6) DEMONSTRATES ALMOST NO VISIBLE REACTION, INDICATING A POSSIBLE MIX UP OF THE SAMPLE TUBES ON (B)(6) 2011. A MIX-UP OF THE SECONDARY TUBES AT THE CUSTOMER'S SITE CANNOT BE EXCLUDED AND MIGHT BE THE ROOT CAUSE FOR THE FALSELY LOW RESULT. DUE TO THIS, THE CUSTOMER HAS DECIDED TO PERFORM D-DIMER TESTING ONLY OUT OF PRIMARY TUBES AND NOT OUT OF SEPARATED SECONDARY TUBES. D-DIMER IS A DEGRADATION PRODUCT OF CROSSLINKED FIBRIN. THE D-DIMER CONCENTRATION IS A MEASURE OF THE FIBRINOLYTIC ACTIVITY OF PLASMIN IN THE VASCULAR SYSTEM. WITH A NORMAL D-DIMER VALUE, ACUTE VEIN THROMBOSIS AND PULMONARY EMBOLISMS (PE) MAY BE RULED OUT WITH VERY HIGH RELIABILITY. THE D-DIMER RESULT SHOULD NOT BE USED IN ISOLATION BUT IN COMBINATION WITH A CLINICAL PROBABILITY ASSESSMENT LIKE THE WELLS SCORE. IT HAS BEEN REPORTED THAT PATIENTS WITH A DISTAL DVT OR A SUBSEGMENTAL/ PERIPHERAL PE MAY HAVE A NORMAL TINA-QUANT D-DIMER RESULT.

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT WAS A DELAY IN DIAGNOSIS. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE D-DIMER GENERATION 2 (D-DIMER) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.08 MG FEU/L WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE COMPLAINT STATES "IN THE MEANTIME, THE PATIENT DEVELOPED A PULMONARY EMBOLISM AND NEEDS INTENSIVE CARE." THE D-DIMER RESULTS FROM A NEW SAMPLE WERE HIGH. NO SPECIFIC DATA WAS PROVIDED. ON (B)(6) 2011, THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 5.77 MG FEU/L. ON (B)(6) 2011, THE USER CONFIRMED "THAT SHE SEES FIBRIN FILAMENTS AND CAN "CATCH/PICK THEM WITH AN EPPENDORF PIPETTE". THEY ARE INDEED VERY THIN AND EASILY TO BE OVERSEEN." THE D-DIMER REAGENT LOT NUMBER WAS 630457-01. THE FIELD SERVICE REPRESENTATIVE CHECKED THE PERFORMANCE OF THE ANALYZER BY PERFORMING PRECISION TESTING ON QUALITY CONTROL MATERIAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 040 YR Other PARACETAMOL