BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC D-DIMER

    MDR report key: 5049473 · Received September 2, 2015

    Report

    Report Number
    1823260-2015-04075
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 17, 2015
    Report Date
    October 13, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE RESULT FOR THE SAMPLE TAKEN FROM THE PATIENT AT THE HOSPITAL THAT WAS INITIALLY REPORTED AS "BELOW 1 UG/ML" WAS ACTUALLY 0.7 UG/ML.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE CUSTOMER'S H232 METER WAS SUBMITTED FOR INVESTIGATION AND TESTING WAS PERFORMED WITH RELEVANT RETENTION MATERIAL. THE RESULTS OF ALL MEASUREMENTS FULFILLED THE REQUIREMENTS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE D-DIMER RESULTS FOR ONE PATIENT SAMPLE FROM COBAS H232 METER SERIAL NUMBER (B)(4). THE COBAS H232 METER OR A SIMILAR PRODUCT IS NOT SOLD IN THE UNITED STATES. THE SPECIFIC DATE OF TESTING WAS NOT KNOWN. THE INITIAL RESULT WAS 3.5 UG/ML. DUE TO THE HIGH RESULT, THEY TOOK ANOTHER SAMPLE FROM THE PATIENT AND THE RESULT WAS 3.59 UG/ML. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS THEN HOSPITALIZED WHERE A NEW SAMPLE WAS TAKEN A FEW HOURS LATER AND THE RESULT WAS BELOW 1 UG/ML ON AN ANALYZER FROM "(B)(6) USING A IMMUNOMETRIC METHOD WITH MONOCLONAL ANTIBODIES". NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580332 ROCHE CARDIAC D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1