DIMENSION VISTA®
Received Mar 26, 2018 · Event occurred Oct 4, 2017
Report 2517506-2018-00195 · MDR key 7371142
Device
Generic name
Dimension Vista® Multi 1 Sample Diluent
Manufacturer
Siemens Healthcare Diagnostics Inc.Catalog number
KD693 SMN 10469971
Lot number
7BDA81
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
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, (B)(4) DATED (B)(6) 2018 AND URGENT FIELD SAFETY NOTICE (B)(4) DATED (B)(6) 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
A FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED ON A CAP SURVEY SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS SCORED AS UNACCEPTABLE BY THE CAP. THE CUSTOMER STATED THAT NO PATIENT SAMPLES HAVE BEEN AFFECTED.
Remedial action
- Recall