DIMENSION VISTA®

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT DIMENSION VISTA® MULTI 1 SAMPLE DILUENT (MULTI 1 SDIL) LOT 7BDA81 MAY HAVE AN INCOMPLETE SLIT ON THE SEPTUM IN THE CAP OF THE VIAL. A DILUENT CAP WITH A DEFECTIVE SEPTUM HAS THE POTENTIAL TO CAUSE ERRONEOUSLY ELEVATED RESULTS IF A SAMPLE IS AUTODILUTED ONBOARD THE DIMENSION VISTA SYSTEM, DUE TO A REDUCED VOLUME OF DILUENT BEING PIPETTED FROM THE VIAL. MULTI 1 SAMPLE DILUENT (MULTI 1 SDIL) IS USED FOR DILUTIONS OF SAMPLES EXCEEDING THE ANALYTICAL MEASUREMENT RANGE WITH THE DIMENSION VISTA® ESTRADIOL (E2) FLEX REAGENT CARTRIDGE. URGENT MEDICAL DEVICE RECALL, VC-18-04.A.US DATED MARCH 21, 2018 AND URGENT FIELD SAFETY NOTICE VC-18-04.A.OUS DATED MARCH 2018 WERE ISSUED TO CUSTOMERS WHO HAD BEEN SHIPPED DIMENSION VISTA® MULTI 1 SAMPLE DILUENT ( MULTI 1 SDIL) LOT 7BDA81 TO INFORM THEM OF THE ISSUE.

Description of Event or Problem

DISCORDANT ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE ORIGINAL SAMPLES WHICH HAD BEEN TESTED BY AUTO-DILUTION WERE REPEATED BY MANUAL DILUTION AND LOWER RESULTS WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AUTO-DILUTION RESULTS.