BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 6052614 · Received October 24, 2016

    Report

    Report Number
    2517506-2016-00382
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 29, 2016
    Report Date
    January 10, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JLS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS REQUESTED MORE INFORMATION FROM THE ACCOUNT TO ASSIST IN THE INVESTIGATION. THE ACCOUNT PROVIDED HETEROPHILE ANTIBODY BLOCKING TUBE (HBT) DATA. AFTER HBT TUBE TREATMENT, THE SAMPLE RESULT WAS ALMOST THE SAME = 5.28 NG/ML AS THE ORIGINAL VALUES (FIRST RESULT AT 9:33 AM = 5.54 NG/ML) ; 2ND RESULT AT 11:29 = 5.42 NG/ML ; 3RD RESULT AT 11:30 = 5.50NG/ML). THE ACCOUNT DID NOT PROVIDE A LIST OF ANY MEDICATIONS THAT THE PATIENT MAY HAVE BEEN TAKING, AND IF THEY WERE UNDERGOING IN VITRO FERTILIZATION THERAPY. NO OTHER TESTS WERE REPEATED ON AN ALTERNATE METHODOLOGY. THE CUSTOMER HAS STOPPED USING THE PROG FERTILITY TEST AND HAS NOT AGREED TO PROVIDE FURTHER INFORMATION. THE SIEMENS HEADQUARTERS SUPPORT CENTER INVESTIGATION HAS BEEN CONCLUDED AS NO FURTHER INFORMATION IS FORTHCOMING FROM THE ACCOUNT. ROOT CAUSE OF THE INCIDENT ON THE SINGLE PATIENT REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATES THAT THE CAUSE FOR THE FALSELY ELEVATED PROG RESULT IS UNKNOWN. THE PROG FLEX REAGENT CARTRIDGE INSTRUCTIONS FOR USE LIMITATIONS OF PROCEDURE SECTION STATES: 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 FROM ALL PATIENT SPECIMENS 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

    DISCREPANT ELEVATED PROGESTERONE (PROG) RESULTS (INITIAL AND REPEAT) WERE OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS LATER REPEATED AT AN ALTERNATE LABORATORY ON AN ALTERNATE NON-SIEMENS METHODOLOGY AND A LOWER RESULT WAS OBTAINED AND REPORTED. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCREPANT ELEVATED PROGESTERONE (PROG) RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT ELEVATED PROGESTERONE (PROG) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702926 DIMENSION VISTA® DIMENSION VISTA® PROGESTERONE FLEX® REAGENT CARTRIDGE JLS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 16179BA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR