BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1970524 · Received January 25, 2011

    Report

    Report Number
    1823260-2011-00387
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIF
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE AMMONIA RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 401 UMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON THIS COBAS 6000 C501 ANALYZER WHICH RECOVERED 51 UMOL/L. THE SAMPLE WAS REPEATED AGAIN ON ANOTHER COBAS 6000 C501 ANALYZER (SERIAL NUMBER (B)(4)) AND RECOVERED 27 UMOL/L. THE CUSTOMER IMMEDIATELY REPORTED THE CORRECT RESULT OF 27 UMOL/L RESULT TO THE NURSE. THE NURSE HAD NOT SEEN THE INITIAL AMMONIA RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE AMMONIA REAGENT LOT NUMBER WAS 62961001. THE FIELD SERVICE REPRESENTATIVE AND THE FIELD APPLICATION SPECIALIST DETERMINED THE EXTERNAL PROBE RINSE WATER WAS LOW WHICH DID NOT ALLOW FOR ADEQUATE RINSING OF THE R2 PROBE. THE FIELD SERVICE REPRESENTATIVE ADJUSTED THE WASHING MECHANISM AND REPEATED THE PATIENT SAMPLES. THE PATIENT RESULTS WERE ACCEPTABLE. THE CUSTOMER RAN QUALITY CONTROL WHICH RECOVERED WITHIN ESTABLISHED RANGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1