BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PHENYTOIN

    MDR report key: 2070210 · Received April 27, 2011

    Report

    Report Number
    1823260-2011-02274
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DIP
    PMA / PMN Number
    K030428
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE PHENYTOIN RESULTS FOR ONE PATIENT SAMPLE FROM THE COBAS C501 SERIAL NUMBER (B)(4). THE ORIGINAL RESULT FROM COBAS C501 SERIAL NUMBER (B)(4) WAS 6.6 UG/ML. THE FIRST ALIQUOT FROM THE SAMPLE WAS SENT TO A REFERENCE LAB FOR TESTING ON AN OLYMPUS INSTRUMENT. THE RESULT WAS 16.5 UG/ML ON (B)(6) 2011, THE LABORATORY SENT A SECOND ALIQUOT TO THE REFERENCE LABORATORY AND THE RESULT WAS 17.6 UG/ML. THE USER REQUESTED THE FIRST ALIQUOT BE RETURNED FROM THE REFERENCE LAB. ON (B)(6) 2011, THE USER TESTED THE FIRST ALIQUOT ON COBAS C501 SERIAL NUMBER (B)(4) AND RECOVERED 8.0 UG/ML. ON (B)(6) 2011, THE USER SENT A THIRD ALIQUOT TO A DIFFERENT REFERENCE LABORATORY TO BE TESTED ON AN "AXIM INSTRUMENT". THE RESULT WAS 19.2 UG/ML. THE ORIGINAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE USER DECLINED A SERVICE VISIT AND STATED SHE FELT THIS ISSUE WAS SPECIFIC TO THE PATIENT SAMPLE AND NOT TO THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS PHENYTOIN ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN DIP ROCHE DIAGNOSTICS NA 15011100

    Patients

    Seq Age Sex Outcome Treatment
    1 DILANTIN| FLUCONAZOLE