BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 6997354 · Received November 2, 2017

    Report

    Report Number
    2517506-2017-00797
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 7, 2017
    Report Date
    March 28, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    NDR
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2517506-03/22/2018-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL MDR 2517506-2017-00797 WAS FILED 02-NOV-2017 VERSUS THE DIMENSION VISTA 500 INSTRUMENT. MDR 2517506-2017-00797 SUPPLEMENT 1 WAS FILED 20-DEC-2017 VERSUS THE MULTI 1 SDIL PRODUCT. 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.

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR 2517506-2017-00797 WAS FILED (B)(6) 2017 VERSUS THE DIMENSION VISTA 500 INSTRUMENT. SIEMENS HEADQUARTERS SUPPORT CENTER CONDUCTED AN INVESTIGATION OF THE DISCORDANT FALSELY ELEVATED ESTRADIOL RESULTS OBTAINED UPON SAMPLE AUTO-DILUTION. IT WAS CONFIRMED THAT E2 OUTLIER RESULTS WERE OBTAINED WHILE PERFORMING AUTO-DILUTION WHEN USING MULTI1 SAMPLE DILUENT (MULTI 1 SDIL) KD693 - LOT 7BDA81. SIEMENS IS CONTINUING TO INVESTIGATE THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER ABOUT THE DISCORDANT FALSELY ELEVATED E2. THE CAUSE OF THE DISCORDANT FALSELY ELEVATED E2 RESULT IS UNKNOWN. THE INCIDENT IS UNDER INVESTIGATION BY THE SIEMENS HEADQUARTERS SUPPORT CENTER (HSC).

    Description of Event or Problem · 1

    A DISCORDANT ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE ORIGINAL SAMPLE WHICH HAD BEEN TESTED BY AUTO-DILUTION WAS REPEATED BY MANUAL DILUTION AND A LOWER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE PATIENT'S STIMULATION PROTOCOL WAS STOPPED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED E2 RESULT OR TREATMENT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777772 DIMENSION VISTA® DIMENSION VISTA® MULTI 1 SDIL SAMPLE DILUENT NDR SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA 500 INTERNATIONAL 7BDA81

    Patients

    Seq Age Sex Outcome Treatment
    1