BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA PHENYTOIN 200

    MDR report key: 2147776 · Received July 1, 2011

    Report

    Report Number
    1823260-2011-03600
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 11, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MOJ
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO RAW DATA OF THE DISCREPANT SAMPLE MEASUREMENT WAS PROVIDED; THEREFORE A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. AN AIR BUBBLE IN THE TUBE WAS MOST LIKELY THE CAUSE. IN THIS CASE THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LAB, THUS, THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE PHENYTOIN RESULTS FOR ONE PATIENT SAMPLE WHEN TEST ON AN INTEGRA 800 ANANLYZER, SERIAL (B)(4). THE ISSUE BEGAN IN MAY. ALL REPEAT TESTING WAS PERFORMED ON THE SAME INTEGRA 800 ANALYZER. THE INITIAL PHENYTOIN RESULT WAS 36.7 UG/ML AND WAS REPORTED OUTSIDE THE LABORATORY. "SOMEONE" REQUESTED THE SAMPLE BE RERUN. THE SAME SAMPLE WAS REPEATED USING A VARIETY OF SAMPLE CONTAINERS. THE FIRST REPEAT RESULT WAS 16.3 UG/ML. THIS VALUE WAS REPORTED IN A CORRECTED REPORT. THE SECOND REPEAT RESULT WAS 15.8 UG/ML. THE THIRD REPEAT RESULT WAS 16.3 UG/ML. THE FINAL REPEAT RESULT WAS 15.9 UG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE CUSTOMER DECLINED A FIELD DISPATCH. SHE FELT THIS WAS A PATIENT SPECIFIC ISSUE, POSSIBLY RELATED TO A BUBBLE IN THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA PHENYTOIN 200 FLUORESCENCE POLARIZATION IMMUNOASSAY, DIPHENYLHYDANTOIN (FREE) MOJ ROCHE DIAGNOSTICS NA 62946501

    Patients

    Seq Age Sex Outcome Treatment
    1