BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMMONIA

    MDR report key: 2072083 · Received April 28, 2011

    Report

    Report Number
    1823260-2011-02305
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 7, 2011
    Report Date
    January 18, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIF
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE, BUT BACTERIAL CONTAMINATION OF THE INSTRUMENT WAS MOST LIKELY THE CAUSE. ALTHOUGH THE BACTERIAL CULTURES DID NOT SHOW ANY GROWTH, DECONTAMINATION OF THE INSTRUMENT AND FREQUENT MAINTENANCE ACTIONS IMPROVED THE SITUATION. NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN TAIWAN.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE AMMONIA RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS C501 ANALYZER. THE INITIAL RESULT WAS 203.5 UG/DL WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY AS 204 UG/DL. THE REPEAT RESULT WAS 44.8 UG/DL. THE PATIENT WAS NOT ADVERSELY AFFECTED AND THE DOCTOR BELIEVED THE REPEAT RESULT TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMMONIA ENZYMATIC METHOD, AMMONIA JIF ROCHE DIAGNOSTICS NA 635969

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR SIRUTA INHALATION| NEXIUM| DIFLUCAN| FELINAMIN| CLONOPAM| TRENTAL| TOPOMAX| PROGRAF| LYO-POVIGEN| BAKTAR VALCYTE| KEFADIM| CEFTAZIDIM| PREDNISOLONE| MORIAMINE