BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2032243 · Received March 29, 2011

    Report

    Report Number
    2517506-2011-00054
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LEH
    PMA / PMN Number
    K061655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 VANCOMYCIN RESULT IS SAMPLE INTEGRITY. THE IFU FOR THE DIMENSION VISTA VANCOMYCIN FLEX REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "SPECIMENS SHOULD BE FREE OF PARTICULATE MATTER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED VANCOMYCIN RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA(R) ANALYZER AND A HIGHER 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 VANCOMYCIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM VANCOMYCIN FLEX(R) REAGENT CARTRIDGE LEH SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 10327BA

    Patients

    Seq Age Sex Outcome Treatment
    1