BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 2061419 · Received April 18, 2011

    Report

    Report Number
    1823260-2011-02093
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 22, 2011
    Report Date
    October 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD BE DETERMINED. NO ADDITIONAL INFORMATION WAS PROVIDED FOR FURTHER INVESTIGATION. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE D-DIMER VALUES OBTAINED ON 2 SAMPLES FROM 2 PATIENTS. UNITS OF MEASURE FOR THE RESULTS WERE NOT PROVIDED. FOR PATIENT 1, THE CUSTOMER OBTAINED A D-DIMER OF 665 ON THE MODULAR P800 P1 MODULE. ON THE P2 MODULE, THE CUSTOMER OBTAINED A D-DIMER OF 627, WHICH THEY MULTIPLIED BY 1.1 DUE TO USING A CITRATE PLASMA SPECIMEN, YIELDING 690. THE SAME SAMPLE WAS TESTED ON THE COBAS H232 CARDIAC SYSTEM WITH A D-DIMER OF EITHER < 0.1 OR < 100; IT IS UNCLEAR FROM THE DATA PROVIDED. THE RESULT OBTAINED ON A SYSMEX SYSTEM WAS "NEG." THE SAMPLE WAS TESTED ON A COBAS C501 ANALYZER; THE RESULT WAS "NEGATIVE." FOR PATIENT 2, THE CUSTOMER OBTAINED A D-DIMER OF 1057 ON THE MODULAR P800 P1 MODULE. ON THE P2 MODULE, THE CUSTOMER OBTAINED A D-DIMER OF 1157. THE SAME SAMPLE WAS TESTED ON THE COBAS H232 CARDIAC SYSTEM WITH A D-DIMER OF EITHER < 0.1 OR < 100; IT IS UNCLEAR FROM THE DATA PROVIDED. THE RESULT OBTAINED ON A SYSMEX SYSTEM WAS "NEG." THE SAMPLE WAS TESTED ON A COBAS C501 ANALYZER; THE RESULT WAS "NEGATIVE." THE LOT NUMBER OF THE D-DIMER REAGENT WAS NOT PROVIDED. THERE WAS NO ALLEGATION OF DEATH OR SERIOUS INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1