BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA AMMONIA 150

    MDR report key: 2673245 · Received July 27, 2012

    Report

    Report Number
    1823260-2012-03879
    Event Type
    Malfunction
    Date Received
    July 27, 2012
    Date of Event
    July 24, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFJ
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THIS ISSUE IS MOST LIKELY DUE TO DECOMPOSITION OF THE REAGENT. THE WORKAROUND IS TO MIX AND RECALIBRATE THE REAGENT CASSETTE PRIOR TO PERFORMING ANY MEASUREMENTS. IN ADDITION, THE CUSTOMER SET UP A RULE IN THEIR SOFTWARE WHICH WILL TRIGGER A RERUN IF INITIAL AMMONIA RESULTS ARE TOO HIGH.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE AMMONIA RESULT ON THEIR C501 ANALYZER. THE PATIENT'S SAMPLE WAS ALIQUOTED INTO A FALSE BOTTOM TUBE BEFORE TESTING. THE INITIAL AMMONIA RESULT WAS 202.4 UMOL/L. THE RESULT WAS TELEPHONED TO THE DOCTOR WHOM IMMEDIATELY QUESTIONED THE RESULT. THE CUSTOMER STATED THE INITIAL RESULT WAS HELD BY THE COBAS IT 3000 AND NOT OFFICIALLY RELEASED FROM THE LABORATORY. THE CUSTOMER STATED THE SAMPLE WAS REPEATED ABOUT 20 MINUTES LATER. THE REPEAT RESULTS WERE 64.7 UMOL/L AND 63.5 UMOL/L. THE DOCTOR WAS CONTACTED AND WAS HAPPY WITH THE AMENDED RESULT. AS A PRECAUTION, ANOTHER SAMPLE WAS TAKEN FROM THE PATIENT AND MEASURED IN DUPLICATE. THE RESULTS AGREED WITH THE RE-RUNS OF THE FIRST SAMPLE AND WERE AROUND 60 UMOL/L. THE PATIENT DID NOT HAVE ITS TREATMENT ALTERED IN ANY WAY IN RESPONSE TO THE DISCREPANT RESULT. THE AMMONIA REAGENT LOT NUMBER WAS 653922 AND THE EXPIRATION DATE WAS 05/30/2013. THE REACTION MONITOR FOR THE DISCREPANT RESULT WAS OVERLAID ONTO THE REPEAT RESULTS AND SHOWED SIMILAR KINETICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA AMMONIA 150 ENZYMATIC METHOD, AMMONIA JFJ ROCHE DIAGNOSTICS NA 653922

    Patients

    Seq Age Sex Outcome Treatment
    1