BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMMONIA

    MDR report key: 3102535 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02836
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIF
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED ISSUE WITH AMMONIA RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES FROM COBAS C501 SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE PATIENT WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. ALL RESULTS ARE IN UMOL/L. THE INITIAL RESULT WAS 104 AND WAS REPORTED OUTSIDE THE LABORATORY. THE NURSE QUESTIONED THE RESULT AS THE PATIENT WAS RECEIVING LACTULOSE TO LOWER THE PATIENT'S AMMONIA LEVEL AND THEY DID NOT EXPECT THE RESULT TO BE HIGHER THAN THE PATIENT'S PREVIOUS RESULT. THE SAMPLE WAS REPEATED THE ORIGINAL ANALYZER WITH TWO DIFFERENT REAGENT CASSETTES. THE RESULT FROM THE FIRST CASSETTE WAS (103.7) 104 AND THE RESULT FROM THE SECOND CASSETTE WAS 64 WITH A DATA FLAG. THE SAMPLE WAS ALSO REPEATED ON ANOTHER COBAS C501 ANALYZER AT THE SITE AND THE RESULT WAS 104. THE PATIENT WAS REDRAWN AND TWO SAMPLES WERE RECEIVED. ON THE ORIGINAL ANALYZER, THE RESULT FROM THE FIRST TUBE WITH THE FIRST REAGENT CASSETTE WAS 97.7. THE RESULT WITH THE SECOND REAGENT CASSETTE WAS 48.8 WITH A DATA FLAG. THE SECOND TUBE WAS TESTED ON THE OTHER COBAS C501 ANALYZER AT THE SITE AND THE RESULT WAS 49. THIS RESULT WAS BELIEVED TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED. DUE TO THE ERRONEOUS RESULT, THE DOCTOR HAD INCREASED THE LACTULOSE DOSE. IT WAS ADMINISTERED TO THE PATIENT JUST BEFORE THE CORRECTED RESULT WAS REPORTED. NO ADVERSE EVENT OCCURRED DUE TO THIS TREATMENT. THE CUSTOMER REFUSED A SERVICE VISIT AND STATED SHE BELIEVED THE ISSUE WAS DUE TO THE REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204267 AMMONIA ENZYMATIC METHOD, AMMONIA JIF ROCHE DIAGNOSTICS NA 67213901

    Patients

    Seq Age Sex Outcome Treatment
    1 LACTULOSE