BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3021130 · Received March 26, 2013

    Report

    Report Number
    2517506-2013-00107
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JIY
    PMA / PMN Number
    K061793
    Removal / Correction Number
    2517506-10-08-2012-015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 IRON RESULTS IS REAGENT CARTRIDGE WELL CONTAMINATION. DIMENSION VISTA IRON IS COMPOSED OF TWO REAGENTS IN DIFFERENT WELLS. ELEVATED RESULTS OCCUR FOR 15 RESULTS, WHICH REPRESENTS A WELL SET COMPOSED OF A WELL OF EACH REAGENT. SIEMENS HAS DETERMINED THAT THE ELEVATED RESULTS ARE DUE TO ENVIRONMENTAL CONTAMINATION OF A REAGENT WELL, WHICH RESULTS IN THE ELEVATION OF RESULTS BY THE SAME MAGNITUDE FOR THE GROUP. WHEN A WELL IS CONTAMINATED WITH TRACE AMOUNTS OF IRON, THE ENTIRE WELL SET IS IMPACTED TO THE SAME MAGNITUDE. AN URGENT MEDICAL DEVICE CORRECTION DATED SEPTEMBER 2012, COMMUNICATION (B)(4), WAS ISSUED TO ALL DIMENSION VISTA IRON CUSTOMERS; TO NOTIFY THEM OF THE ISSUE, THE POTENTIAL RISK TO HEALTH, AND ACTIONS TO BE TAKEN BY CUSTOMERS. WORKAROUND INSTRUCTIONS WERE PROVIDED TO CUSTOMERS TO FIRST DISABLE THE NORMAL FLOW OF IRON TESTING; TO BATCH THE PROCESSING OF IRON TEST IN GROUPS OF 15 ON THE INSTRUMENT, AND TO RUN QC ON EACH WELL SET TO DETERMINE IF THE WELL SET IS CONTAMINATED. USER ERROR CONTRIBUTED TO THE EVENT. ALTHOUGH THE ACCOUNT ACKNOWLEDGED AWARENESS OF THE URGENT MEDICAL DEVICE CORRECTION WORKAROUND, THEY WERE NOT FOLLOWING THE INSTRUCTIONS TO RUN QC ON EACH WELL SET. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS RECEIVED A COMPLAINT FROM THE CUSTOMER OF ELEVATED RESULTS ON DIMENSION VISTA IRON. FALSELY ELEVATED RESULTS WERE OBTAINED ON PATIENT SAMPLES. PATIENT RESULT WERE REPORTED TO THE PHYSICIAN. THE MAGNITUDE OF THE ELEVATION OF RESULTS FROM THIS CUSTOMER WAS APPROXIMATELY 70 UG/DL. THE PATIENT SAMPLES WERE REPEATED AND CORRECTED RESULTS ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED IRON RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124267 DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM IRON FLEX® REAGENT CARTRIDGE JIY SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 12277BC

    Patients

    Seq Age Sex Outcome Treatment
    1