BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT D-DIMER

    MDR report key: 3747774 · Received April 14, 2014

    Report

    Report Number
    1823260-2014-02620
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 30, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K062203
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE D-DIMER RESULT FOR ONE PATIENT. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER TESTED THE PATIENT'S SAMPLE WITH THE D-DIMER ASSAY ON A (B)(4) ANALYZER. THE RESULT WAS 10.61 UG/ML. INFORMATION ON WHETHER THE RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER SUSPECTED THE RESULT WAS FALSELY HIGH AND RETURNED THE PATIENT'S SAMPLE FOR INVESTIGATION. THE SAMPLE WAS TESTED WITH THE D-DIMER ASSAY ON AN INTEGRA 400 PLUS ANALYZER AND THE RESULT WAS 8.87 UG/ML. THE SAMPLE WAS TESTED WITH A HEXAMATE D-DIMER ASSAY FROM MEDICAL AND BIOLOGICAL LABORATORIES CO. LTD ON A STA-R EVOLUTION ANALYZER AND THE RESULT WAS 1.46 UG/ML. THE SAMPLE WAS TESTED WITH A STA LIATEST D-DIMER ASSAY ON A STA-R EVOLUTION ANALYZER AND THE RESULT WAS 1.70 UG/ML. THERE WERE NO DEATHS, INJURIES, ILLNESSES, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULTS. THE CUSTOMER WOULD NOT PROVIDE INFORMATION ON WHETHER THE PATIENT WAS HARMED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226438 TINA-QUANT D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1