BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 5928345 · Received September 6, 2016

    Report

    Report Number
    1823260-2016-01310
    Event Type
    Malfunction
    Date Received
    September 6, 2016
    Date of Event
    August 12, 2016
    Report Date
    September 6, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLY LOW RESULTS FOR APPROXIMATELY 5 PATIENT SAMPLES TESTED FOR CHOL2 CHOLESTEROL GEN.2 (CHOL) ON A C702 ANALYZER. OF THE FIVE SAMPLES, ONE HAD AN ERRONEOUS CHOL RESULT THAT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 19.3 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE ERROR WAS FOUND WHEN THE SAMPLE WAS REPEATED ON (B)(6) 2016, RESULTING AS 216.2 MG/DL. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CHOL REAGENT LOG NUMBER WAS 160578, WITH AN EXPIRATION DATE OF 03/31/2017. DURING INVESTIGATIONS, IT WAS NOTED UPON REVIEW OF THE DATA THAT THERE WAS A POSSIBILITY THAT A SMALLER SAMPLE VOLUME WAS EJECTED INTO THE CUVETTE DURING THE INITIAL RUN. IT WAS ADVISED TO CHECK THE SAMPLE PROBE FOR POTENTIAL BLOCKAGES CAUSED BY ISSUES WITH PRE-ANALYTIC SAMPLE HANDLING. THE FIELD SERVICE ENGINEER FLUSHED THE REAGENT SYRINGES WITH BLEACH AND CLEANED VALVES BEHIND THE SYRINGE BLOCK. AFTER THESE ACTIONS, THE GEAR PUMP PRESSURE ROSE, INDICATING A CHANGE. THE GEAR PUMP PRESSURE WAS ALSO CORRECTED. THE ISSUE WAS REPORTED TO BE SOLVED AFTER THE ACTIONS PERFORMED BY THE FIELD SERVICE ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581358 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR