BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1971658 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00448
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER ISSUES WERE REPORTED AFTER THE MAINTENANCE PERFORMED BY THE FIELD SERVICE REPRESENTATIVE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER SPORADICALLY RECEIVED QUESTIONABLE CREATININE PLUS GENERATION 2 (CREATININE) RESULTS OVER ONE AND A HALF MONTHS. FOUR PATIENT SAMPLES WERE INVOLVED; HOWEVER THE USER PROVIDED DATA FOR ONLY TWO PATIENT SAMPLES, OF WHICH ONLY ONE WAS REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS 609 UMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS ADMITTED TO THE ER FOR A "COUPLE OF HOURS" FOR EXAMINATION. THE USER STATED THIS "CAUSED STRESS ON BEHALF OF THE PATIENT". THE SAMPLE WAS REPEATED AND THE RESULT WAS 52.8 UMOL/L. THE RESULT FROM A NEW SAMPLE DRAWN FROM THE PATIENT A COUPLE OF HOURS LATER WAS 49.4 UMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED AND WAS CURRENTLY FEELING FINE. THE CREATININE REAGENT LOT NUMBER WAS 630928. THE FIELD SERVICE REPRESENTATIVE FOUND A DROP OF ACID WASH ON THE WASHING STATION WHICH WOULD DRIP BACK INTO SOME OF THE CUVETTES. HE RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JFY ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR ALENNAT