BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 5062231 · Received September 8, 2015

    Report

    Report Number
    2517506-2015-00179
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    July 24, 2015
    Report Date
    August 10, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CGX
    PMA / PMN Number
    K132638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT CREATININE (CR2) ELEVATED RESULTS RELATIVE TO RECOVERIES BY AN ALTERNATE METHODOLOGY IS UNKNOWN. THE ACCOUNT SITE SWITCHED PATIENT TESTING FOR CREATININE TO THE ENZYMATIC CREATININE METHOD. THE ISSUE IS UNDER INVESTIGATION BY SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Description of Event or Problem · 1

    AN ACCOUNT COMPLAINED OF DISCORDANT CREATININE (CRE2) ELEVATED RESULTS RELATIVE TO RECOVERIES BY AN ALTERNATE METHODOLOGY. THE ACCOUNT HAS NOTED ELEVATED CRE2 RESULT SINCE PLACING THE REAGENT INTO USE ON THE DIMENSION EXL 200 IN (B)(6) 2015. PATIENT RESULTS WERE REPORTED TO PHYSICIANS. THE ACCOUNT REPEATED THE SAMPLES WITH AN ALTERNATE DIMENSION REAGENT (ENZYMATIC CREATININE -EZCR) LOWER RESULTS WERE OBTAINED IN ALIGNMENT WITH PHYSICIAN EXPECTATIONS. PATIENT TREATMENT WAS ALTERED ON THE BASIS OF THE DISCORDANT ELEVATED CRE2 RESULT. PATIENT CHEMOTHERAPY TREATMENTS WERE WITHHELD DUE TO THE SHIFT IN CRE2 VALUES AS COMPARED TO SERUM CREATININE VALUES OBTAINED PRIOR TO USING THE EXL 200. PATIENTS SCHEDULED FOR CT SCANS WERE UNABLE TO RECEIVE CONTRAST MEDIA DUE TO THE SHIFT IN SERUM CREATININE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED CRE2 RESULTS OR ALTERATIONS IN TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593366 DIMENSION® CLINICAL CHEMISTRY SYSTEM CREATININE FLEX® REAGENT CARTRIDGE CGX SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW FA6093

    Patients

    Seq Age Sex Outcome Treatment
    1