BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 3980001 · Received August 5, 2014

    Report

    Report Number
    1823260-2014-05868
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 19, 2014
    Report Date
    August 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE C-REACTIVE PROTEIN GEN.3 (CRP) RESULTS FOR ONE PATIENT ON THEIR C702 ANALYZER. THE PATIENT'S SAMPLE WAS PROCESSED BY THE CUSTOMER'S MODULAR PRE ANALYTICS DEVICE AND TESTED IN A SAMPLE CUP. THE PATIENT'S INITIAL CRP RESULT WAS 378.3 MG/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:2 AND THE RESULT WAS 139.2 MG/L. THE CUSTOMER STATED THIS WAS THE PROBLEM RESULT. THE SAMPLE WAS THEN TRANSFERRED TO A FALSE BOTTOM TUBE AND REPEATED. THE FIRST RESULT FROM THE NEW TUBE WAS 383.2 MG/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:2 AND THE RESULT WAS 367.8 MG/L. THE SAMPLE WAS THEN DILUTED OFF LINE AND THE RESULT WAS 171.1 MG/L. INFORMATION ON WHETHER THE DISCREPANT RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE CRP REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE REACTION KINETICS OF THE DISCREPANT RESULT SHOWED THAT INSUFFICIENT SAMPLE WAS ASPIRATED. IT WAS NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED CUP ADAPTORS. THIS MAY CAUSE INCORRECT SAMPLE PIPETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457647 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1