BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 6060523 · Received October 27, 2016

    Report

    Report Number
    2517506-2016-00344
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 24, 2016
    Report Date
    October 27, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    NDR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. SIEMENS HEADQUARTERS SUPPORT CENTER REPRESENTATIVES HAVE CONCLUDED THAT THE PATTERN OF REPEATABLE ELEVATED E2 RESULTS OF APPROXIMATELY THE SAME VALUE OBTAINED ON MULTIPLE SAMPLES FROM THE SAME PATIENT WITH LOWER RESULTS ON AN ALTERNATE, NON-SIEMENS METHODOLOGY IS STRONGLY SUGGESTIVE OF NON-SPECIFIC HETEROPHILIC ANTIBODY BINDING. NO SAMPLE HAS BEEN PROVIDED FOR SIEMENS INVESTIGATION. 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 INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCREPANT 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 LEVEL WAS OBTAINED AND A CORRECTED REPORT WAS ISSUED. THERE IS NO INDICATION THAT TREATMENT WAS PRESCRIBED OR ALTERED ON THE BASIS OF THE DISCREPANT ELEVATED ESTRADIOL (E2) RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT ELEVATED ESTRADIOL (E2) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712801 DIMENSION VISTA® DIMENSION VISTA® E2 ESTRADIOL FLEX® REAGENT CARTRIDGE NDR SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 16055AC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR