BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA D-DIMER

    MDR report key: 2991525 · Received March 6, 2013

    Report

    Report Number
    1823260-2013-01353
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    November 29, 2012
    Report Date
    October 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K062203
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE PATIENT'S RESULT FROM (B)(6) 2013 WAS 15.32 UG/ML.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION PROVIDED BY THE CUSTOMER. ADDITIONAL DETAILS WERE REQUESTED BUT NOT PROVIDED. THE CALIBRATION RESULTS WERE COMPARABLE WITH OTHER CALIBRATIONS AND THE QUALITY CONTROL DATA WERE STABLE AND WITHIN RANGE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TINA-QUANT D-DIMER RESULTS. THE PATIENT WAS BORN IN 1989. NO OTHER PATIENTS WERE AFFECTED BY THIS EVENT. ON (B)(6) 2012, THE PATIENT'S D-DIMER RESULT WAS 14.2 MG/L ON AN INTEGRA 800, SERIAL NUMBER NOT PROVIDED. THE RESULT WAS THOUGHT TO HAVE BEEN REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS SENT TO THE EMERGENCY ROOM DUE TO THIS RESULT. ON (B)(6) 2012, THE PATIENT'S D-DIMER RESULT WAS 1.4 MG/L ON A MODULAR P800 MODULE, SERIAL NUMBER (B)(4). THE P-MODULE RESULT FIT WITH THE PATIENT'S OTHER FINDINGS, AND THE HIGH INTEGRA RESULT WAS IGNORED. NO IMAGING TESTING WAS PERFORMED SINCE THE NEW D-DIMER RESULT WAS LOW. NO THROMBOSIS WAS FOUND AND NO ANTI- COAGULATION TREATMENT WAS STARTED. ON (B)(6) 2012, THE PATIENT'S D-DIMER RESULT WAS 15.3 MG/L FROM THE INTEGRA 800. THE SAMPLE WAS REPEATED ON A BECKMAN AU680 ANALYZER, AND THE RESULT WAS 0.25 MG/L. THE SAMPLE WAS THEN TESTED ON AN INTEGRA 400 ANALYZER, SERIAL NUMBER NOT PROVIDED, AND THE RESULT WAS 12 MG/L. THE SAMPLE WAS THEN DILUTED AND REPEATED ON THE INTEGRA 400 AND THE RESULT WAS 9.8 MG/L. THE SAMPLE WAS THEN TESTED ON THE MODULAR P ANALYZER AND THE RESULT WAS 1.4 MG/L. ON (B)(6) 2013, THE PATIENT'S D-DIMER RESULT FROM THE INTEGRA 800 WAS 11.4 MG/L. THE SAMPLE WAS THEN TESTED ON THE INTEGRA 400 AND THE RESULT WAS 12.81 MG/L. THE SAMPLE WAS THEN TESTED ON THE P-MODULE AND THE RESULT WAS 1.64 MG/L. IT WAS UNCLEAR WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT HARMED BY THIS EVENT. THE CUSTOMER THOUGHT THE ISSUED WAS DUE TO AN INTERFERENCE IN THE PATIENT'S SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96009 COBAS INTEGRA D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA 667722

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR