BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 2792699 · Received October 16, 2012

    Report

    Report Number
    1823260-2012-05152
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 28, 2012
    Report Date
    February 21, 2013
    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

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. THE FIELD SERVICE REPRESENTATIVE NOTED THAT THE RINSE LINES WERE VERY DIRTY AND CLOGGED WHICH INDICATED THE FLUIDIC SYSTEM WAS NOT MAINTAINED ACCORDING TO GUIDELINES. FURTHER STUDIES PERFORMED BY THE FIELD SERVICE REPRESENTATIVE INDICATE THE ISSUE IS RESOLVED. NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN THE (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED ISSUE WITH QC FOR CREATININE PLUS VER 2 CREATININE). AS PART OF THE INVESTIGATION, THE CUSTOMER REPEATED PATIENT SAMPLES ORIGINALLY TESTED ON (B)(6) 2012 OVER A FEW DAYS BEGINNING (B)(6) 2012 ON COBAS C702 ANALYZER SERIAL NUMBER (B)(4). QUESTIONABLE CREATININE RESULTS FOR 348 PATIENT SAMPLES WERE DISCOVERED. OF THE DATA PROVIDED, THE RESULTS FOR 278 WERE DISCREPANT. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE CREATININE REAGENT LOT NUMBER WAS 667126. THE EXPIRATIONS DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1