DIMENSION VISTA® SYSTEM

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED COMPLAINTS OF AN INCREASE IN THE RATE OF "ABNORMAL ASSAY" ERRORS AND CALIBRATION FAILURES WITH THE DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE LOTS 15175MA, 15204MA, 15246MA AND 15267MA. THE ERRORS CAN OCCUR ON CALIBRATION, QC AND/OR PATIENT SAMPLES. AS STATED IN THE DIMENSION VISTA OPERATOR'S GUIDE, RESULTS WITH "ABNORMAL ASSAY" FLAGS ARE NOT REPORTABLE. SIEMENS ISSUED AN URGENT MEDICAL DEVICE RECALL COMMUNICATION (B)(4) DATED NOVEMBER 2015 TO CUSTOMERS WHO HAD ORDERED THE IMPACTED LOTS ADVISING THEM TO DISCONTINUE THE USE OF THE LOT.

Description of Event or Problem

THE CUSTOMER COMPLAINED OF OBTAINING ABNORMAL ASSAY E143 FLAGS ON CALIBRATION SAMPLES WITH THE BETA-2 MICROGLOBULIN (B2MIC) FLEX (R) REAGENT CARTRIDGE LOT 15204MA ON THE DIMENSION VISTA INSTRUMENT. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE ABNORMAL ASSAY FLAGS ON B2MIC RESULTS. THERE IS NO INDICATION OF ADVERSE PATIENT IMPACT DUE TO THE ABNORMAL ASSAY FLAGS ON B2MIC RESULTS.