BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1980995 · Received February 8, 2011

    Report

    Report Number
    1823260-2011-00678
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 19, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DAP
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN THE (B)(6).

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE SAMPLE REVEALED THAT A IGM INTERFERENCE MIGHT HAVE CAUSED THE QUESTIONABLE D-DIMER RESULT. POSSIBLE IGM INTERFERENCE IS DESCRIBED IN PRODUCT LABELING. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE TINA-QUANT D-DIMER (D-DIMER) RESULT FOR ONE PATIENT SAMPLE. THE PATIENT HAD A VENOUS EMBOLISM THREE MONTHS AGO AND THE D-DIMER RESULT AT THAT TIME WAS 13,000 UG/L. AFTER A THREE MONTH ANTICOAGULATION PERIOD, THE D-DIMER RESULT WAS 5000 UG/L ALTHOUGH THERE WAS NO CLINICAL, NOR ULTRASOUND EVIDENCE FOR A RESIDUAL THROMBOSIS. THE SAMPLE WAS SENT TO ANOTHER HOSPITAL USING THE LIATEST ON THE STAGO PLATFORM. THE D-DIMER RESULT WAS 246 UG/L. THE SAMPLE WAS ALSO TESTED ON A POINT-OF-CARE ANALYZER, PATHFAST, SYSMEX CORPORATION, WHICH GAVE A RESULT OF <500 UG/L. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE D-DIMER REAGENT LOT NUMBER WAS 631582.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER DAP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR IBUPROFEN