BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PHENYTOIN/200

    MDR report key: 1827906 · Received September 8, 2010

    Report

    Report Number
    1823260-2010-05314
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MOJ
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED DISCREPANT PHENYTOIN CRITICAL RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS C501 MODULE (B)(4). THE INITIAL PHENYTOIN RESULT WAS 36.3 UG/ML (ACCOMPANIED BY DATA FLAGS). THE SAMPLE WAS REPEATED SEVEN TIMES: THE FIRST REPEAT RESULT WAS 37.0 UG/ML (ACCOMPANIED BY DATA FLAGS). THIS RESULT WAS CALLED TO THE PHYSICIAN AS A CRITICAL VALUE. THE SECOND REPEAT RESULT, TESTED ON A COBAS INTEGRA 400 ANALYZER, GAVE 27.5 UG/ML (ACCOMPANIED BY A DATA FLAG). THE THIRD REPEAT RESULT, TESTED 08/21/2010 ON A COBAS INTEGRA 400 ANALYZER, GAVE 26.7 UG/ML (ACCOMPANIED BY A DATA FLAG). THE FOURTH REPEAT RESULT, TESTED (B)(6)2010 ON A COBAS INTEGRA 400 ANALYZER, GAVE 25.7 UG/ML (ACCOMPANIED BY A DATA FLAG). THE FIFTH REPEAT RESULT, TESTED (B)(6)2010 ON A COBAS INTEGRA 400 ANALYZER, GAVE 27.3 UG/ML (ACCOMPANIED BY A DATA FLAG). THE SIXTH REPEAT RESULT, TESTED ON (B)(6)2010 ON ORIGINAL ANALYZER, GAVE 24.9 UG/ML (ACCOMPANIED BY A DATA FLAG). THE SEVENTH REPEAT RESULT, TESTED (B)(6)2010 ON ORIGINAL ANALYZER, GAVE 25.6 UG/ML (ACCOMPANIED BY A DATA FLAG). THIS RESULT WAS CALLED TO THE PHYSICIAN AS A CORRECTED REPORT. THE CUSTOMER CONSIDERED THE 36.3 UG/ML AND THE 37.0 UG/ML TO BE ERRONEOUS RESULTS. THE PHYSICIAN DETERMINED THE TWO PHENYTOIN RESULTS REPORTED TO HIM (37.0 UG/ML AND 25.6 UG/ML) WOULD BE IN THE SAME RANGE FOR DOSING AND THAT NO CHANGE OF MEDICATION WAS INITIATED BASED ON THE 37.0 UG/ML RESULT. THE PATIENT WAS NOT AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE PHENYTOIN NEEDED TO BE RE-CALIBRATED. HE VERIFIED THERE WERE NO ISSUES WITH THE HARDWARE BY PERFORMING MECHANICAL CHECKS. THE FIELD SERVICE REPRESENTATIVE ALSO RAN A PRECISION STUDY WHICH WAS WITHIN SPECIFICATION. THE CUSTOMER RE-CALIBRATED THE PHENYTOIN AND RAN QUALITY CONTROL WHICH WAS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS PHENYTOIN/200 COMPETITIVE BINDING, PHENYTOIN MOJ ROCHE DIAGNOSTICS NA 14827800

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR PHENYTOIN