BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE PLUS VER.2

    MDR report key: 2103635 · Received May 26, 2011

    Report

    Report Number
    1823260-2011-02806
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K024098
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE RECEIVING QUESTIONABLE RESULTS FOR CREATININE ON THEIR COBAS C501 (SERIAL NUMBER (B)(4)). THERE WAS ONE DISCREPANT RESULT REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT FOR CALCIUM, BUT CREATININE WAS REPEATED AND IS ALSO DISCREPANT. THE PATIENT HAD A RE-DRAW TESTED AND THE INITIAL SAMPLE RE-TESTED. ALL THE REPEAT TESTING WAS PERFORMED ON THE SAME C501 ANALYZER. ALL TESTS WERE PERFORMED ON (B)(6) 2011. THE INITIAL CREATININE RESULT WAS 0.15 MG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT FROM THE ORIGINAL SAMPLE WAS 1.65 MG/DL ACCOMPANIED BY A DATA FLAG. THE RESULT FROM THE RE-DRAW WAS 1.65 MG/DL ACCOMPANIED BY A DATA FLAG. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE EVENT WAS CAUSED BY A LEAK IN THE VACUUM TUBING. HE REPLACED THE VACUUM TUBING. HE PERFORMED PRECISION TESTING WITH PASSING RESULTS. THE CUSTOMER CALIBRATED AND RAN QUALITY CONTROL WITH PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CREATININE PLUS VER.2 ENZYMATIC METHOD, CREATININE JFY ROCHE DIAGNOSTICS NA 63741901

    Patients

    Seq Age Sex Outcome Treatment
    1 085 YR