BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-DIMER

    MDR report key: 4330089 · Received December 15, 2014

    Report

    Report Number
    1823260-2014-09966
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Date of Event
    May 28, 2014
    Report Date
    January 27, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GHH
    PMA / PMN Number
    K033491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ANALYZER WAS PROVIDED FOR INVESTIGATION. RETENTION MATERIALS WERE TESTED ON THE CUSTOMER'S ANALYZER AND ALL MEASUREMENTS FULFILL REQUIREMENTS. TEST STRIPS FROM THE CUSTOMER SITE WERE REQUESTED FOR INVESTIGATION, BUT THESE COULD NOT BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    RETENTION MATERIALS WERE TESTED AND THE RESULTS OF ALL MEASUREMENTS FULFILL REQUIREMENTS.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED THAT THEY HAVE RECEIVED QUESTIONABLE RESULTS FOR A TOTAL OF FOUR PATIENTS TESTED FOR ROCHE CARDIAC D-DIMER (DDI) ON A COBAS H232 METER WHEN COMPARED TO THE D-DIMER METHOD ON A SIEMENS CA 1500 INSTRUMENT. OF THE FOUR PATIENTS, TWO HAD RESULTS THAT WERE ERRONEOUS. THE FIRST PATIENT HAD A SAMPLE TESTED FOR DDI AND IT RESULTED AS 0.41 UG/ML ON (B)(6) 2014. THE FIRST PATIENT ALSO HAD ANOTHER SAMPLE TESTED ON THE SIEMENS CA 1500 INSTRUMENT AND IT RESULTED AS 1.3 MG/L FEU FOR D- DIMER ON (B)(6) 2014. THE SECOND PATIENT, A MALE BORN ON (B)(6) 1943, HAD A SAMPLE TESTED FOR DDI AND IT RESULTED AS 0.34 UG/ML ON (B)(6) 2014. THE SECOND PATIENT ALSO HAD ANOTHER SAMPLE TESTED ON THE SIEMENS CA 1500 INSTRUMENT AND IT RESULTED AS 0.8 MG/L FEU FOR D-DIMER ON (B)(6) 2014. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE SERIAL NUMBER OF THE COBAS H232 METER IS KS0206555. THIS METER IS NOT SOLD IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820988 D-DIMER FIBRIN SPLIT PRODUCTS GHH ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR