BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC D-DIMER

    MDR report key: 3716622 · Received April 1, 2014

    Report

    Report Number
    1823260-2014-02245
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K033491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE IDENTIFIED. NO PRODUCTS WERE RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION NEEDED FOR FURTHER INVESTIGATION WAS REQUESTED BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE EVENT TOOK PLACE IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ROCHE CARDIAC D-DIMER (DDI) TEST. THE TEST WAS PERFORMED ON CARDIAC READER, SERIAL NUMBER (B)(4). THE INITIAL DDI RESULT WAS 1.2 UG/ML. THE TEST WAS REPEATED TWICE WITH RESULTS OF 0.78 AND 0.92 UG/ML. THE CUSTOMER WOULD ONLY STATE THE TEST WAS REPORTED OUTSIDE THE LABORATORY AS "POSITIVE." THE SPECIFIC DATE OF TESTING WAS REQUESTED, BUT THE CUSTOMER WOULD NOT PROVIDE THE INFORMATION. THERE WERE NO ADVERSE EVENTS. THE LOT NUMBER AND EXPIRATION DATE OF THE TEST STRIPS WERE REQUESTED BUT WERE NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196322 ROCHE CARDIAC D-DIMER FIBRINOGEN/FIBRIN DEGREDATION PRODUCTS ASSAY GHH ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1