BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC D-DIMER 10 TESTS (COBAS)

    MDR report key: 2760574 · Received September 26, 2012

    Report

    Report Number
    1823260-2012-04830
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE COBAS H232 FOR INVESTIGATION. RETENTION STRIPS FROM LOT NUMBER 28100110 WERE TESTED ON THE DEVICE USING A SPIKED BLOOD SAMPLE. THE RESULTS OF THE TESTING MET REQUIREMENTS. THE VIDAS BIOMERIEUX MEASUREMENTS ARE NOT COMPATIBLE WITH THE COBAS H232 MEASUREMENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY RECEIVED A FALSE NEGATIVE CARDIAC D-DIMER RESULT ON THEIR COBAS H232 METER, SERIAL NUMBER (B)(4). THE PATIENT'S INITIAL D-DIMER RESULT WAS 0.35 UG/ML FROM A HEPARIN WHOLE BLOOD SAMPLE AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT SHOWED CLEAR SIGNS OF THROMBOSIS. 15 MINUTES LATER THE PATIENT HAD A NEW SAMPLE TAKEN AND SENT TO AN EXTERNAL LABORATORY FOR TESTING ON A VIDAS ANALYZER USING A CITRATE BLOOD SAMPLE. THE REPEAT RESULT WAS 690 UG/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS REFERRED TO A HOSPITAL FOR A "DUPLEX SONOGRAPHY". THE PATIENT WAS NOT HARMED BY ANY ACTION TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE CARDIAC D-DIMER 10 TESTS (COBAS) FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY GHH ROCHE DIAGNOSTICS NA DD0011

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR ARIXTRA