BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CHEMISTRY SYSTEM

    MDR report key: 2677870 · Received August 1, 2012

    Report

    Report Number
    2517506-2012-00164
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Date of Event
    July 18, 2012
    Report Date
    July 19, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    DKJ
    PMA / PMN Number
    K904301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED SALICYLATE RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED

    Description of Event or Problem · 1

    A SERIES OF FALSELY ELEVATED SALICYLATE (SAL) RESULTS WERE OBTAINED ON A PATIENT'S SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. THE SAMPLES WAS REPEATED ON AN ALTERNATE SYSTEM AND LOWER, NEGATIVE RESULTS WERE OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED SAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CHEMISTRY SYSTEM SALICYLATE FLEX® REAGENT CARTRIDGE DKJ SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW AE3078

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR