BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2871407 · Received December 13, 2012

    Report

    Report Number
    1823260-2012-06313
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 29, 2012
    Report Date
    January 16, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE REACTION MONITORS INDICATED THE DISCREPANT RESULT WAS CAUSED BY A DISTURBANCE BETWEEN MEASURING POINTS, AFFECTING HOW THE RESULT WAS CALCULATED. AS THE SYSTEM WAS RUNNING WITHIN SPECIFICATION DURING THE SERVICE VISIT, A ROOT CAUSE FOR THE DISTURBANCE COULD NOT BE DETERMINED. AS THE MEASUREMENTS RETURNED TO NORMAL AFTER THE DISTURBED MEASURING POINTS, AN INTERFERENCE IN THE MEASURING CELL COULD BE EXCLUDED. THIS EVENT WAS MOST LIKELY CAUSED BY A DISTURBANCE IN THE REACTION BATH. THE ACTIONS TO AVOID PARTICLES OR CONTAMINATION IN THE REACTION BATH ARE DESCRIBED IN THE OPERATOR'S MANUAL.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE VANCOMYCIN RESULT ON THEIR C501 ANALYZER. THE PATIENT'S SAMPLE WAS INITIALLY ALIQUOTED ON THE CUSTOMER'S MODULAR PRE ANALYTICS DEVICE AND TESTED IN AN ALIQUOT CUP. THE REPEAT TEST WAS PERFORMED FROM THE ORIGINAL SAMPLE TUBE. THE PATIENT'S INITIAL VANCOMYCIN RESULT WAS 48.5 UMOL/L AND IT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 29.8 UMOL/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THE SAMPLE WAS REPEATED TWO MORE TIMES FROM THE ORIGINAL TUBE AND THE RESULTS WERE 29.8 UMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE VANCOMYCIN REAGENT LOT NUMBER WAS 665958 AND THE EXPIRATION DATE WAS 05/30/2013. THE FIELD SERVICE REPRESENTATIVE PERFORMED AN INSTRUMENT CHECK TEST, WHICH SHOWED THE ANALYZER WAS PERFORMING WELL. HE DETERMINED THERE WAS NO COAGULATION INHIBITOR IN THE SAMPLE AND IT WAS PROCESSED AS RECOMMENDED. HE CHECKED THE RINSE AND WATER LEVELS ON THE RINSE AND WASHING STATIONS AND INSPECTED THE PROBES FOR CLEANLINESS. THEY WERE ALL PERFORMING WELL AND IN GOOD WORKING ORDER. THE SPECIAL WASHES LISTED ON THE ANALYZER WERE CORRECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR