DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM

Additional Manufacturer Narrative

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

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.