BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2352911 · Received November 30, 2011

    Report

    Report Number
    2517506-2011-00166
    Event Type
    Malfunction
    Date Received
    November 30, 2011
    Date of Event
    November 20, 2011
    Report Date
    November 20, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    DKJ
    PMA / PMN Number
    K904301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED SALICYLATE RESULT WAS SAMPLE INTEGRITY. THE IFU FOR DIMENSION SALICYLATE FLEX REAGENT CARTRIDGES CONTAINS THE FOLLOWING INFORMATION: "FOLLOW THE INSTRUCTIONS WITH YOUR SPECIMEN COLLECTION DEVICE FOR USE AND PROCESSING." AND "SPECIMENS SHOULD BE FREE OF PARTICULATE MATTER." NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED SALICYLATE RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS RE-RUN ON AN ALTERNATE INSTRUMENT AND AN ELEVATED RESULT WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED SALICYLATE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM SALICYLATE FLEX® REAGENT CARTRIDGE DKJ SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DA2183

    Patients

    Seq Age Sex Outcome Treatment
    1