BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2221300 · Received August 24, 2011

    Report

    Report Number
    1823260-2011-04529
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 4, 2011
    Report Date
    December 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JID
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE EVENT COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. A CONNECTION BETWEEN THE GEAR PUMP PRESSURE AND A SINGLE HIGH RESULT COULD NOT BE FOUND. INCORRECT SAMPLE HANDLING DURING SAMPLE PREPARATION COULD HAVE PRODUCED A SINGLE HIGH RESULT, HOWEVER THIS COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED FOR INVESTIGATION. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLY HIGH AMMONIA RESULT ON THEIR COBAS C501. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT WITH A DISCREPANT RESULT WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT TESTING WAS PERFORMED ON THE SAME C501 ANALYZER. THE PATIENT'S INITIAL AMMONIA RESULT WAS 208 UG/DL ACCOMPANIED BY A DATA FLAG. THE PATIENT THEN HAD BLOOD RE-DRAWN AND THE RESULT WAS 75 UG/DL. THE CUSTOMER THEN REPEATED THE ORIGINAL SAMPLE AND THE RESULT WAS 111 UG/DL ACCOMPANIED BY A DATA FLAG. THE CUSTOMER BELIEVED THE RESULTS OF 75 UG/DL AND 111 UG/DL WERE CORRECTED AND THEY WERE ISSUED AS A CORRECTED REPORT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED LOW GEAR PUMP PRESSURE WAS THE CAUSE OF THE EVENT. HE ADJUSTED THE GEAR PUMP PRESSURE. AS A PRECAUTION, HE CLEANED THE INCUBATOR BATH, VACUUM WASTE VALVES, PROBE WASH STATIONS, AND PROBES. A MECHANICAL CHECK TEST WAS PERFORMED WITH NO ERRORS. THE CUSTOMER RAN PRECISION TESTS AND QUALITY CONTROL ALL WITH PASSING RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1