BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA (R) SYSTEM

    MDR report key: 4100687 · Received September 19, 2014

    Report

    Report Number
    1226181-2014-00474
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 K RESULT IS UNKNOWN. A SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER SERVICE ENGINEER WAS DISPATCHED TO THE SITE. THE SYSTEM WAS EXAMINED AND NO OBVIOUS MALFUNCTIONS WERE IDENTIFIED WITH THE INSTRUMENT. 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 PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND A LOWER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED K RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED K RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581760 DIMENSION VISTA (R) SYSTEM DIMENSION VISTA (R) SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD DIMENSION VISTA(R) 1500

    Patients

    Seq Age Sex Outcome Treatment
    1