BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 7787093 · Received August 15, 2018

    Report

    Report Number
    2517506-2018-00459
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    July 20, 2018
    Report Date
    August 15, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    NDR
    UDI-DI
    00842768026461
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE CUSTOMER CARE CENTER CONCERNING DISCORDANT ELEVATED ESTRADIOL RESULT. SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) EVALUATED THE INFORMATION PROVIDED AND CONCLUDED THEIR INVESTIGATION OF THE EVENT. NO INSTRUMENT, QC, OTHER PATIENT RESULT, OR ASSAY RELATED ISSUES WERE REPORTED. NO E2 ASSAY OR VISTA SYSTEM ISSUES HAVE BEEN IDENTIFIED. THE CAUSE OF THE DISCORDANT ELEVATED ESTRADIOL RESULT IS UNKNOWN. RESULTS WERE QUESTIONED BY THE PROVIDER AS HIGHER RESULTS THAN WERE EXPECTED. IT IS UNCLEAR WHEN THE SAMPLE WAS DRAWN IN RELATIONSHIP TO THE REMOVAL OF THE OVARIES. HERE THE ESTRADIOL RESULT WAS BELIEVED TO BE ERRONEOUSLY ELEVATED COMPARED TO TWO OTHER METHODS. THE PATIENT WAS ON ORAL CONTRACEPTIVE MEDICATION, LOETTE, WHICH CONTAINS ESTRADIOL. THE IFU INDICATES UNDER THE LIMITATIONS OF PROCEDURE SECTION: "WITH THE ADVENT OF STEROID BASED MEDICATIONS (ANALOGUES) WITH SIMILAR CHEMICAL STRUCTURES TO ESTRADIOL, THERE IS THE POSSIBILITY OF CROSS-REACTIVITY AND RESULTS INCONSISTENT WITH THE PATIENTS CLINICAL HISTORY". THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED ON A PATIENT'S SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE SAME SAMPLE WAS TESTED BY TWO ALTERNATE NON-SIEMENS METHODOLOGIES AND LOWER RESULTS WERE OBTAINED CONSISTENT WITH PHYSICIAN EXPECTATIONS. THERE ARE NO REPORTS OF TREATMENT CHANGE OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED E2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628878 DIMENSION VISTA® DIMENSION VISTA® E2 ESTRADIOL FLEX® REAGENT CARTRIDGE NDR SIEMENS HEALTHCARE DIAGNOSTICS INC. 18039BB 00842768026461

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR