BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 6367199 · Received February 28, 2017

    Report

    Report Number
    2517506-2017-00140
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 28, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    NDR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT ELEVATED E2 RESULT IS UNKNOWN. A SIEMENS HEADQUARTERS SUPPORT CENTER REPRESENTATIVE EVALUATED THE INFORMATION PROVIDED. THERE WAS NO INDICATION AN INSTRUMENT ISSUE SINCE THE RESULT REPLICATED ACROSS DIFFERENT DIMENSION VISTAS AT THE SITE. NO HETEROPHILIC ANTIBODY TESTING WAS CONDUCTED BY THE CUSTOMER OR SIEMENS. NO SAMPLE WAS PROVIDED FOR SIEMENS EVALUATION. WHILE IT WAS COMMENTED THAT THE PATIENT WAS NOT ON MEDICATIONS, THE FOLLOWING STATEMENT FROM THE IFU CAUTIONS CUSTOMERS: "WITH THE ADVENT OF NEW 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. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. IF THE ESTRADIOL RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT." THE INSTRUCTIONS FOR USE FOR THE E2 FLEX® REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY HAS BEEN DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES. NEVERTHELESS, COMPLETE ELIMINATION OF THIS INTERFERENCE CANNOT BE GUARANTEED. A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PATIENT HISTORY SHOULD BE INTERPRETED WITH CAUTION." 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 SAMPLE ON THE DIMENSION VISTA SYSTEM. THE RESULT WAS REPORTED TO A PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS TESTED WITH A DIFFERENT, NON-SIEMENS METHODOLOGY. A LOWER RESULT WAS OBTAINED AND A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED E2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147945 DIMENSION VISTA® DIMENSION VISTA® E2 ESTRADIOL FLEX® REAGENT CARTRIDGE NDR SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 16277BB

    Patients

    Seq Age Sex Outcome Treatment
    1