BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CREATININE REAGENT

    MDR report key: 4171576 · Received October 14, 2014

    Report

    Report Number
    2050010-2014-00001
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    CGX
    PMA / PMN Number
    K071277
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE (FIELD SERVICE ENGINEER) EVALUATED THE INSTRUMENT AND SUSPECTED AN ISSUE WITH THE CREATININE REAGENT ON BOARD THE INSTRUMENT SINCE THE ISSUE BEGAN WHEN THE REAGENT BOTTLE WAS INITIALLY LOADED. AFTER LOADING THE REAGENT BOTTLE, CALIBRATION PASSED BUT QC (QUALITY CONTROL) FAILED TWICE. QC PASSED THE THIRD TIME WITH RECOVERY CLOSE TO THE -2SD (STANDARD DEVIATION) ASSIGNED TARGET MEAN VALUE. NO INFORMATION ON THE SHIPPING CONDITIONS OR REAGENT PREPARATION WAS PROVIDED. THE FSE DISCARDED THE CREATININE REAGENT ON BOARD THE SYSTEM AND REPLACED IT WITH A NEW BOTTLE. THE MANUFACTURE AND EXPIRATION DATE OF THE CREATININE REAGENT ARE UNKNOWN. AFTER CREATININE REAGENT WAS REPLACED, CALIBRATION AND QUALITY CONTROL PASSED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING AN ELEVATED CREM (CREATININE) RESULT FOR ONE PATIENT, INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. CREATININE REAGENT IS USED IN CONJUNCTION WITH THE UNICEL DXC SYNCHRON SYSTEMS. THE CUSTOMER REPEATED THE SAMPLE ON ANOTHER DXC AND OBTAINED A LOWER CREM RESULT. THE INITIAL AND RERUN RESULT WAS WITHIN THE CIS CREM REFERENCE INTERVAL RANGE. THE ELEVATED CREM RESULT WAS REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THERE WAS AN AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QUALITY CONTROL WAS WITHIN LABORATORY'S ESTABLISHED RANGES PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650110 SYNCHRON CREATININE REAGENT ALKALINE PICRATE, COLORIMETRY, CREATININE CGX BECKMAN COULTER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1