BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMMONIA

    MDR report key: 4692040 · Received April 13, 2015

    Report

    Report Number
    8020890-2015-00002
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Date of Event
    January 19, 2015
    Report Date
    February 2, 2015
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Product Code
    JIF
    PMA / PMN Number
    K030873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SAMPLE WILL RECOVER WITH A POSITIVE BIAS OF APPROXIMATELY 60 UMOL/L WHEN USING AMMONIA CATALOGUE NUMBER AM1054 BATCH 326180. ALL AFFECTED CUSTOMERS HAVE BEEN CONTACTED AND INSTRUCTED TO DISCONTINUE USE AND DISCARD, THEIR INVENTORY WILL BE REPLACED. THE AMMONIA TEST IS GENERALLY ORDERED ALONG WITH GLUCOSE, UREA, ELECTROLYTES, KIDNEY AND LIVER FUNCTIONS TESTS ALP, AST AND ALT THEREFORE IT IS NOT CONSIDERED A SINGLE CONCLUSIVE DIAGNOSTIC TEST TO INITIATE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244919 AMMONIA AMMONIA JIF RANDOX LABORATORIES, LTD. NA 326180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA