BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3693567 · Received March 21, 2014

    Report

    Report Number
    2517506-2014-00044
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    July 2, 2013
    Report Date
    March 6, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MKW
    PMA / PMN Number
    K062236
    Removal / Correction Number
    2517506-03-19-2014-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THE COMPLAINT FOR UNDER-RECOVERY OF QC AND PATIENT SAMPLES WITH THE DIMENSION VISTA® CSA FLEX® REAGENT CARTRIDGE WHEN WHOLE BLOOD SAMPLES ARE RUN FROM SMALL SAMPLE CONTAINER (SSC) IN PATIENT MODE. INVESTIGATION BY SIEMENS CONFIRMS THAT CSA, AS WELL AS CSAE, UNDER-RECOVERS BY 18% TO 44% WHEN WHOLE BLOOD SAMPLES ARE RUN FROM SSC IN PATIENT MODE. SIEMENS ISSUED AN URGENT MEDICAL DEVICE CORRECTION COMMUNICATION (B)(4) IN MARCH 2014 TO NOTIFY CUSTOMERS OF THE ISSUE. CUSTOMERS WERE ADVISED: ""DO NOT USE SMALL SAMPLE CONTAINERS (SSC) WHEN RUNNING WHOLE BLOOD SAMPLES WITH DIMENSION VISTA® CSA AND DIMENSION VISTA® CSAE ASSAYS. PLEASE PROCESS CSA AND CSAE SAMPLES ACCORDING TO THE INSTRUCTIONS FOR USE: - SAMPLES SHOULD BE MIXED BY INVERSION (GENTLY INVERT THE TUBE TEN TIMES) OR IN A ROCKER TO OBTAIN UNIFORM DISTRIBUTION OF CYCLOSPORINE IN WHOLE BLOOD. DO NOT VORTEX. AVOID THE FORMATION OF FOAM. - TRANSFER 200 UL (190 - 210 UL) OF THE WHOLE BLOOD SAMPLE INTO A SAMPLE CUP. - PROCESS SAMPLES AS STAT AND NO MORE THAN ONE RACK EVERY 5 MINUTES. - PROCESS NO MORE THAN 6 SAMPLES AT A TIME TO PREVENT INCREASED SETTLING OF ERYTHROCYTES."" AN ALERT CARD WILL BE PLACED IN THE FUTURE LOTS OF THE DIMENSION VISTA CSA AND CSAE FLEX® REAGENT CARTRIDGE KITS TO BRING THE ISSUE TO THE CUSTOMER'S ATTENTION. THE IFU FOR BOTH PRODUCTS WILL BE UPDATED TO STATE: DO NOT USE SSC CONTAINERS FOR PROCESSING PATIENT SAMPLES WITH THE VISTA FOR THE CSA AND CSAE ASSAYS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VARIABILITY OF RECOVERY OF QC SAMPLES FOR CYCLOSPORIN A (CSA) DEPENDING UPON THE SAMPLE CUP USED ON THE DIMENSION VISTA INSTRUMENT. SIMILAR VARIABILITY WAS SEEN WITH PATIENT SAMPLES DURING TROUBLESHOOTING OF THE QC OBSERVATION. FALSELY DEPRESSED RESULTS WERE OBTAINED WHEN THE WHOLE BLOOD SAMPLES WERE RUN IN THE SMALL SAMPLE CONTAINER (SSC), PART NUMBER KS860. HIGHER, CORRECT VALUES WERE OBTAINED WHEN RUNNING THE WHOLE BLOOD SAMPLES IN A ROUTINE SAMPLE CUP, PART NUMBER DSC4. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED DUE TO THE FALSELY DEPRESSED CSA RESULTS ON PATIENT SAMPLES IN TROUBLESHOOTING STUDIES. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT THE FALSELY DEPRESSED CSA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169339 DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM CYCLOSPORINE FLEX® REAGENT CARTRIDGE MKW SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1