BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 8001727 · Received October 24, 2018

    Report

    Report Number
    2517506-2018-00605
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    July 3, 2018
    Report Date
    October 24, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Removal / Correction Number
    2517506-10/24/2018-011-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INVESTIGATED THE ISSUE AND DETERMINED THAT IF A TEST(S)/ORDER(S) IS CANCELLED BY THE OPERATOR WHILE THE INSTRUMENT IS ALIQUOTING THE SAMPLE, THE DIMENSION VISTA INSTRUMENT MAY CONTINUE TO DELIVER THE CANCELLED SAMPLE OR VIAL CONTENTS TO THE ALIQUOT WELL(S). FUTURE SAMPLES MAY BE ASSIGNED TO THE SAME ALIQUOT WELL(S) AND BECOME CONTAMINATED WITH THE EXISTING CONTENTS OR OVERFLOW OF THE ALIQUOT WELL MAY OCCUR, POTENTIALLY CONTAMINATING A SURROUNDING WELL(S). THIS ISSUE ONLY OCCURS WHEN AN OPERATOR MANUALLY CANCELS A TEST(S)/ORDER(S) FOR CALIBRATION, QUALITY CONTROL (QC), OR PATIENT SAMPLE WHILE THE INSTRUMENT IS IN THE PROCESS OF ALIQUOTING THE SAMPLE. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) VSW-19-01.A.US WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) VSW-19-01.A.OUS WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS. THE UMDC AND UFSN INDICATE THAT SIEMENS IS WORKING TO PROVIDE AN SOFTWARE UPDATE TO ADDRESS THE ISSUE AND ADVISE CUSTOMERS TO NOT CANCEL TEST(S)/ORDER(S) FOR CALIBRATION, QC, OR PATIENT SAMPLES UNTIL THE INSTRUMENT IS FINISHED WITH ALIQUOTING THE SAMPLE.

    Description of Event or Problem · 1

    DURING AN INTERNAL VALIDATION PROCESS OF THE DIMENSION VISTA SOFTWARE ON A DIMENSION VISTA 1500 INSTRUMENT, SIEMENS DETERMINED THAT A SAMPLE CAN BE UNEXPECTEDLY DILUTED IF THE OPERATOR MANUALLY ORDERS A SPECIAL DILUTION FOR AN ASSAY, WHICH USES SYSTEM DILUENT (SDIL) IN AN ON-BOARD VIAL, AND THEN MANUALLY CANCELS THE ASSAY WHILE IT IS ALIQUOTING. THE ALIQUOT WELL, WHICH CONTAINS SDIL, MAY REMAIN AVAILABLE FOR A NEW PRIMARY ALIQUOT AND LEAD TO AN UNEXPECTED DILUTED SAMPLE. UPON FURTHER INVESTIGATION, SIEMENS DETERMINED THAT IF AN OPERATOR MANUALLY ORDERS A LINEARITY STUDY, USING ON-BOARD CALIBRATOR VIALS, AND WHILE IT IS ALIQUOTING, CANCELS THE STUDY, THE ALIQUOT WELL(S) (WHICH CONTAINS THE CALIBRATOR) MAY BE AVAILABLE FOR A NEW PRIMARY ALIQUOT. THIS WOULD LEAD TO AN UNEXPECTED MIXTURE OF THE SAMPLE AND CALIBRATOR. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FINDINGS FROM SIEMENS' INTERNAL VALIDATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839690 DIMENSION VISTA 1500 DIMENSION VISTA 1500 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1