BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE JAFFÉ METHOD

    MDR report key: 2141731 · Received June 27, 2011

    Report

    Report Number
    1823260-2011-03483
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGX
    PMA / PMN Number
    K921661
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    INTERMITTENTLY FOR TWO DAYS, THE USER RECEIVED QUESTIONABLE CREATININE RESULTS FROM THE ANALYTICAL P MODULE ANALYZER SERIAL NUMBER (B)(4). DATA FOR TWO PATIENT SAMPLES WAS PROVIDED THAT WERE DISCOVERED WHEN PHYSICIANS QUESTIONED THE INITIAL RESULT. THE CREATININE REAGENT WAS REPLACED, CALIBRATION AND QUALITY CONTROL WAS PERFORMED, AND THEN THE PATIENTS WERE REPEATED. PATIENT SAMPLE 1 INITIAL RESULT WAS 2.12 MG/DL AND THE REPEAT RESULT ON (B)(6) 2011 WAS 1.26 MG/DL. PATIENT SAMPLE 2 INITIAL RESULT WAS 2.03 MG/DL AND THE REPEAT RESULT ON (B)(6) 2011 WAS 0.80 MG/DL. PATIENT 2 WAS ADMITTED TO THE HOSPITAL, GIVEN IV FLUIDS AND ALBUMIN. THE PATIENT WAS ALSO TAKEN OFF DIURETICS. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THE REAGENT STIRRER WAS INTERMITTENTLY NOT TURNING AND HE LUBRICATED THE STIRRER. TO VERIFY THE ANALYZER OPERATION, THE USER RAN QUALITY CONTROL AND PRECISION TESTING WHICH WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CREATININE JAFFÉ METHOD ALKALINE PICRATE, COLORIMETRY, CREATININE CGX ROCHE DIAGNOSTICS NA 63831501

    Patients

    Seq Age Sex Outcome Treatment
    1