BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2923304 · Received January 22, 2013

    Report

    Report Number
    1226181-2013-00033
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JIH
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR STATED THAT THE PATIENT SAMPLE WAS RUN IN A LITHIUM HEPARIN TUBE. THE INSTRUCTIONS FOR USE FOR LITHIUM ON DIMENSION INSTRUMENTS STATES: "DO NOT USE COLLECTION TUBES CONTAINING LITHIUM HEPARIUM." THE OPERATOR FOUND A SAMPLE FROM THE PATIENT THAT WAS NOT IN A LITHIUM HEPARIN TUBE AND RERAN THE SAMPLE TO OBTAIN THE CORRECT RESULT. THE CAUSE OF THE FALSELY ELEVATED LITHIUM RESULT IS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED LITHIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE PATIENT WAS IN THE EMERGENCY ROOM, AND WAS DISCHARGED BASED UPON THE DISCORDANT RESULT. THE LABORATORY DISCOVERED THEY HAD USED THE INCORRECT TUBE TYPE, RERAN THE PATIENT SAMPLE, AND ISSUED A CORRECTED REPORT TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED LITHIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30297 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JIH SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1