BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AST

    MDR report key: 2084673 · Received May 11, 2011

    Report

    Report Number
    1823260-2011-02523
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FET
    PMA / PMN Number
    K810393
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE ASPARTATE AMINOTRANSFERASE (AST) RESULT FOR ONE PATIENT SAMPLE FROM THE ANALYTICAL D MODULE ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 89 U/L AND THE REPEAT RESULT WAS 19 U/L. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN DID NOT THINK THE RESULT FIT THE CLINICAL PICTURE AND HE REQUESTED A REPEAT ANALYSIS OF THE SAMPLE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE AST R2 REAGENT LOT NUMBER WAS 63316001. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE FOUND THE CELL BLANK NOZZLES WERE INTERMITTENTLY DRIPPING. HE FLUSHED THE CELL BLANK VALVES AND ADJUSTED THE CELL BLANK LEVEL. TO VERIFY THE ANALYZER OPERATION, HE RAN CALIBRATION AND QUALITY CONTROL WITH RESULTS WITHIN THE SPECIFIED LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AST ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM FET ROCHE DIAGNOSTICS NA 63574001

    Patients

    Seq Age Sex Outcome Treatment
    1