BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENYTOIN

    MDR report key: 3041307 · Received April 8, 2013

    Report

    Report Number
    1823260-2013-02152
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 23, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DIP
    PMA / PMN Number
    K030428
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLES IN QUESTION WERE SUBMITTED FOR FURTHER INVESTIGATION. AS THE PATIENT SAMPLE INTERFERED WITH SEVERAL ASSAYS WHICH INCLUDED DIFFERENT TYPES OF ANTIBODIES, IT WAS DETERMINED THE PATIENT PRODUCED AN ANTIBODY AGAINST THE MICRO PARTICLE SURFACE. PRODUCT LABELING INCLUDES A DISCLAIMER FOR PATIENTS WHO PRODUCE POLYVALENT ANTIBODIES AGAINST THIS SPECIFIC LATEX PARTICLE SURFACE. NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE COMBINATION OF PHENYTOIN REAGENT LOT 66798001 WITH COBAS C501 ANALYZER SERIAL NUMBER (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE PHENYTOIN (DILANTIN) RESULTS FOR FOUR SAMPLES FROM ONE PATIENT ON THE COBAS C501 ANALYZERS SERIAL NUMBER (B)(4). THE RESULTS WERE QUESTIONED BY A DOCTOR AS THE PATIENT WAS RECEIVING DILANTIN FOR SEIZURE ACTIVITY AND THE DOCTOR EXPECTED THE RESULTS TO BE IN THE THERAPEUTIC RANGE. THE SAMPLES WERE REPEATED ON THE SAME COBAS C501 ANALYZERS AND SENT FOR REPEAT TESTING ON A SIEMENS ADVIA AT ANOTHER SITE. ALL RESULTS ARE IN UG/ML. ON (B)(6) 2012 SAMPLE 1: ORIGINAL RESULT WAS 0.8. IT WAS UNKNOWN WHICH COBAS C501 GENERATED THIS RESULT. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.5 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.9 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WITH BIO-RAD LEVEL 3 QC MATERIAL WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WITH BIO-RAD LEVEL 3 QC MATERIAL WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON THE SIEMENS ADVIA WAS 20.2 03/23/2012 SAMPLE 2: ORIGINAL RESULT WAS <0.8. IT WAS UNKNOWN WHICH COBAS C501 GENERATED THIS RESULT. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.2 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 1.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WITH BIO-RAD LEVEL 3 QC MATERIAL WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WITH BIO-RAD LEVEL 3 QC MATERIAL WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON THE SIEMENS ADVIA WAS 22.4. ON (B)(6) 2012 SAMPLE 3: ORIGINAL RESULT WAS <0.8. IT WAS UNKNOWN WHICH COBAS C501 GENERATED THIS RESULT. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.1 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.9 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WITH BIO-RAD LEVEL 3 QC MATERIAL WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WITH BIO-RAD LEVEL 3 QC MATERIAL WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON THE SIEMENS ADVIA WAS 32.38 (32.4). ON (B)(6) 2012 SAMPLE 4: ORIGINAL RESULT WAS <0.8. IT WAS UNKNOWN WHICH COBAS C501 GENERATED THIS RESULT. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.4 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WAS 0.5 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WITH BIO-RAD LEVEL 3 QC MATERIAL WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON COBAS C501 (B)(4) ON (B)(6) 2013 WITH A 1:2 DILUTION WITH BIO-RAD LEVEL 3 QC MATERIAL WAS 0.0 WITH A DATA FLAG. REPEAT RESULT ON THE SIEMENS ADVIA WAS 34.0. ALL OF THE ORIGINAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE RESULTS FROM THE SIEMENS ADVIA WERE BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED AS THE DOCTOR IMMEDIATELY RECOGNIZED THE RESULTS DID NOT FIT THE CLINICAL PICTURE. THE CUSTOMER BELIEVED THE ISSUE TO BE SAMPLE SPECIFIC AND REFUSED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143037 PHENYTOIN ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN DIP ROCHE DIAGNOSTICS NA 66738001

    Patients

    Seq Age Sex Outcome Treatment
    1 093 YR NEXIUM| MANNITOL| DUOCOLOX SUPPOSITORIES| ATIVAN| DILANTIN| ASPIRIN