BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 7103746 · Received December 11, 2017

    Report

    Report Number
    2517506-2017-00871
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 10, 2017
    Report Date
    January 19, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    KXT
    UDI-DI
    00842768028335
    PMA / PMN Number
    K093441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL MDR 2517506-2017-00871 WAS FILED 12/11/2017. MDR 2517506-2017-00861, MDR 2517506-2017-00862, MDR 2517506-2017-00863, MDR 2517506-2017-00864, MDR 2517506-2017-00865, MDR 2517506-2017-00866, MDR 2517506- 2017-00867, MDR 2517506-2017-00868, MDR 2517506- 2017-00869, MDR 2517506-2017-00870, MDR 2517506-2017-00872, MDR 2517506-2017-00873, MDR 2517506-2017-00874, MDR 2517506-2017-00875 WERE ALSO FILED FOR THE SAME CUSTOMER INQUIRY. THE CAUSE FOR THE FALSELY DISCORDANT ELEVATED DIGXN RESULT IS UNKNOWN BASED UPON THE INFORMATION PROVIDED BY THE CUSTOMER. DIGXN QUALITY CONTROL (QC) RECOVERY WAS WITHIN ACCEPTABLE RANGES DURING THE TIME OF THIS ISSUE. THERE WERE NO ADDITIONAL COMPLAINTS ON THE SAME DIGXN LOT 17103BC. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT ELEVATED DIGOXIN (DIGXN) RESULT OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA SYSTEM. SIEMENS REQUESTED THE SAMPLE TO BE RETURNED FOR EVALUATION BUT NONE WAS PROVIDED. SINCE NO SAMPLE IS AVAILABLE FOR FURTHER INVESTIGATION OF THIS SAMPLE, NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    MDR 2517506-2017-00861, MDR 2517506-2017-00862, MDR 2517506-2017-00863, MDR 2517506-2017-00864, MDR 2517506-2017-00865, MDR 2517506-2017-00866, MDR 2517506-2017-00867, MDR 2517506-2017-00868, MDR 2517506- 2017-00869, MDR 2517506-2017-00870, MDR 2517506-2017-00872, MDR 2517506-2017-00873, MDR 2517506-2017-00874, MDR 2517506-2017-00875 WERE ALSO FILED FOR THE SAME CUSTOMER INQUIRY. THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER FOR THE DISCORDANT ELEVATED DIGOXIN RESULT ON THE DIMENSION VISTA INSTRUMENT. QUALITY CONTROL WAS WITHIN SPECIFICATION DURING TESTING. SIEMENS IS INVESTIGATING THE INCIDENT.

    Description of Event or Problem · 1

    A DISCORDANT FALSELY ELEVATED DIGOXIN (DIGXN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS TESTED TWICE EARLIER ON AN ALTERNATE VISTA INSTRUMENT AND HIGH RESULTS WERE OBTAINED. THE SAME SAMPLE WAS REPEATED THREE TIMES LATER ON THE SAME VISTA INSTRUMENT AND HIGH RESULTS WERE OBTAINED. A 1:3 AND 1:2 MANUAL DILUTION WAS PERFORMED ON THE LAST TWO REPEATS AND HIGH RESULTS WERE OBTAINED ON THE SAME SAMPLE. THE CLINICIAN STARTED TO QUESTION THE RESULT SINCE IT HAD INCREASED WHEN NO DIGOXIN WAS GIVEN TO THE PATIENT. THERE IS NO KNOWN REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DIGXN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884158 DIMENSION VISTA® DIMENSION VISTA® DIGXN LOCI DIGOXIN FLEX® REAGENT CARTRIDGE KXT SIEMENS HEALTHCARE DIAGNOSTICS INC 17103BC 00842768028335

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR