BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1920218 · Received December 10, 2010

    Report

    Report Number
    1823260-2010-07368
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHD
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE LOW RESULTS INTERMITTENTLY FOR MULTIPLE ASSAYS ON THE COBAS 6000 C501 ANALYZER. THE EVENT INVOLVED SEVEN PATIENT SAMPLES. TWO PATIENT SAMPLES GAVE DISCREPANT RESULTS FOR CHOLESTEROL GENERATION 2 (CHOL2) WHICH OCCURRED ON (B)(6) 2010. PATIENT SAMPLE 1, THE INITIAL RESULT WAS 9 MG/DL, THE REPEAT RESULT WAS 196 MG/DL. PATIENT SAMPLE 2, THE INITIAL RESULT WAS 9 MG/DL; THE REPEAT RESULT WAS 238 MG/DL. TO THE CUSTOMERS' KNOWLEDGE, NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND DID NOT EXPECT THAT ANY PATIENTS WERE AFFECTED BY THE EVENT. THE REAGENT LOT NUMBER FOR CHOL2 WAS 62476401. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS A PROBLEM WITH THE RINSE UNIT OPERATION. MULTIPLE COMPONENTS WERE REPLACED AND ADJUSTMENTS PERFORMED. PERFORMANCE TESTS WERE RUN AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER CHD ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1