BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3932293 · Received July 14, 2014

    Report

    Report Number
    1226181-2014-00372
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 POTASSIUM RESULT IS SAMPLE INTEGRITY. THE IFU FOR DIMENSION® V-LYTE® IMT SENSOR CONTAINS THE FOLLOWING INFORMATION: "FOLLOW THE INSTRUCTIONS WITH YOUR SPECIMEN COLLECTION DEVICE FOR COLLECTION, TUBE HANDLING, SPIN TIMES, AND G-FORCE ESPECIALLY WHEN USING PLASTIC BLOOD COLLECTION TUBES. FAILURE TO FOLLOW THE BLOOD COLLECTION TUBE INSTRUCTIONS MAY RESULT IN INCREASED MAINTENANCE OR TROUBLESHOOTING OF THE IMT SYSTEM." THE ACCOUNT DOES NOT MEET THE TUBE MANUFACTURER'S RECOMMENDATION FOR SPIN TIMES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA(R) ANALYZER AND A LOWER RESULT WAS OBTAINED. THE PATIENT WAS ADMITTED TO THE FACILITY. IT IS UNKNOWN IF PATIENT TREATMENT WAS OTHERWISE ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED POTASSIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410995 DIMENSION(R) VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION(R) VISTA CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD DIMENSION VISTA(R)

    Patients

    Seq Age Sex Outcome Treatment
    1