BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 1923503 · Received December 14, 2010

    Report

    Report Number
    1823260-2010-07404
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 27, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K071211
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR ALKALINE PHOSPHATASE ACCORDING TO (B)(4) ON THE COBAS C111 ANALYZER FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS - 3 U/L. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH DILUTION WHICH YIELDED A RESULT OF 166 U/L. THE SAMPLE WAS REPEATED A SECOND TIME WHICH RESULTED AT 14 U/L. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2010, THE USER REPEATED THE SAMPLE A FOURTH TIME WHICH YIELDED A RESULT OF 165 U/L. THE ALP2S RESULT OF 165 U/L WAS SENT AS A CORRECTED REPORT. THE PATIENT TRANSFERRED TO ANOTHER HOSPITAL BUT WAS NOT ADMITTED BASED ON THE ERRONEOUS RESULT REPORTED. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS EVENT. THE REAGENT LOT NUMBER FOR ALP2S WAS 62688601. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE REPLACED THE PHOTOMETER LAMP, AND PERFORMED INSPECTION AND MAINTENANCE ACTIONS. PERFORMANCE TESTS WERE RUN WITH ALL RESULTS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS C111 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 006 YR