BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 7376904 · Received March 28, 2018

    Report

    Report Number
    2517506-2018-00196
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    September 27, 2017
    Report Date
    March 28, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    NDR
    UDI-DI
    00842768030314
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2517506-03/22/2018-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    A FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED ON A CAP SURVEY SAMPLE ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULT WAS SCORED AS UNACCEPTABLE BY THE CAP. THERE IS NO INDICATION THAT PATIENT SAMPLES HAVE BEEN AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223295 DIMENSION VISTA® DIMENSION VISTA® MULTI 1 SAMPLE DILUENT NDR SIEMENS HEALTHCARE DIAGNOSTICS INC. 7BDA81 00842768030314

    Patients

    Seq Age Sex Outcome Treatment
    1