BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1604131 · Received February 18, 2010

    Report

    Report Number
    1823260-2010-01105
    Event Type
    Malfunction
    Date Received
    February 18, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 18, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHS
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT CKMB RESULTS FOR MULTIPLE PATIENT SAMPLES COMPARED TO RESULTS RUN ON A COBAS E601 ANALYZER AT THE SITE. PATIENT SAMPLES WERE RUN DURING THE PERFORMANCE OF CORRELATIONS STUDY. SAMPLE TYPE IS PLASMA DRAWN IN BD 13X75 HEPARINIZED GEL SAMPLE TUBES. SAMPLES WERE INITIALLY RUN ON THE COBAS E601 AND REPEATED ON THIS ANALYZER (E2010). ONLY THE FOLLOWING PATIENT SAMPLE WAS PROVIDED WHICH WAS DISCREPANT. INITIAL RESULT GAVE 4.2 NG/ML; REPEAT GAVE 0.8 NG/ML. RESULTS FROM THE COBAS E601 WERE REPORTED. CORRECTED REPORTS WERE NOT ISSUED AS THE CUSTOMER BELIEVED THE RESULTS FROM THE COBAS E601 ANALYZER TO BE CORRECT. CKMB REAGENT LOT NUMBER 15652801 THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO FIND A CAUSE. HE CHANGED SYRINGE SEALS, INSTALLED NEW PINCH TUBING, MIXING BELT AND ADJUSTED S/R PROBE. DIAGNOSTIC AND PERFORMANCE CHECK TESTS WERE PERFORMED, AND CUSTOMER RAN CONTROLS WITH ALL RESULTS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JHS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1