BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHESIS

    MDR report key: 261680 · Received February 7, 2000

    Report

    Report Number
    1217183-2000-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2000
    Date of Event
    January 6, 2000
    Report Date
    February 7, 2000
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED THAT THE IL SYNTHESIS MODEL 1715 REPORTED AN ERRONEOUS COHB RESULT OF 18% AND THAT THE INSTRUMENT DID NOT FLAG THE ERROR. THE QUALITY CONTROLS ALSO REPORTED WITHIN SPECIFICATION. A SITE VISIT BY AN IL FIELD SERVICE REPRESENTATIVE (FSR) SHOWED THAT THE INSTRUMENT WAS NOT BEING MAINTAINED PER LABELING INSTRUCTIONS AND AS A RESULT A FILM FORMED IN THE CUVETTE WINDOW. FURTHERMORE, CLEANING PATHWAY ERRORS HAD BEEN FLAGGED. AFTER CLEANING BY THE FSR, INSTRUMENT RESULTS RETURNED TO NORMAL. BASED ON A FOLLOW-UP CONVERSATION BETWEEN THE SITE AND THE FSR, IT WAS CONCLUDED THAT NO PT WAS TREATED BASED ON THE ERRONEOUS COHB RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHESIS BLOOD GAS/ELECTROLYTE/GLUCOSE/CO-OXIMETER JKS INSTRUMENTATION LABORATORY CO. 1715 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA