BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMMONIA

    MDR report key: 2147752 · Received July 1, 2011

    Report

    Report Number
    1823260-2011-03594
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 17, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFJ
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    REQUESTED INFORMATION WAS NOT PROVIDED FOR FURTHER INVESTIGATION. A ROOT CAUSE COULD NOT BE DETERMINED. ACCORDING TO THE CUSTOMER, THE ISSUE HAS NOT RECURRED. THE INITIAL LOW AMMONIA RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE AMMONIA RESULTS FOR ONE PATIENT SAMPLE WHEN TESTED ON A COBAS 6000 C501 ANALYZER, SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 3.1 UMOL/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND RECOVERED 22 UMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501 ANALYZER (SERIAL NUMBER WAS NOT PROVIDED) AND RECOVERED 68 UMOL/L. IT IS UNKNOWN WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMMONIA CATALYTIC METHODS, AMYLASE JFJ ROCHE DIAGNOSTICS NA 629610

    Patients

    Seq Age Sex Outcome Treatment
    1