BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 14254008 · Received April 29, 2022

    Report

    Report Number
    2517506-2022-00112
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    June 30, 2021
    Report Date
    June 23, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JLW
    UDI-DI
    00842768015731
    PMA / PMN Number
    K140859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN (B)(6) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING A DISCORDANT FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) PATIENT SAMPLE RESULT OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. MDRS 2517506-2022-00108, 2517506-2022-00109, 2517506-2022-00110, 2517506-2022-00111 AND 2517506-2022-00113 ARE FILED FOR THE SAME EVENT. SIEMENS IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (08-JUN-2022): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL AND CALIBRATION RESULTS WERE WITHIN THE CUSTOMER'S EXPECTED RANGES. NO PATIENT SAMPLE WAS PROVIDED TO SIEMENS FOR INTERNAL INVESTIGATION. THE INSTRUCTIONS FOR USE (IFU) FOR THE DIMENSION VISTA- LOCI THYROID STIMULATING HORMONE (TSH) ASSAY 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. AS WITH ANY IMMUNO-RECOGNITION MEASUREMENT OF A PEPTIDE, EXTREMELY RARE GENETIC VARIANTS MAY EXHIBIT VARYING DEGREES OF DETECTION. A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PATIENT HISTORY SHOULD BE INTERPRETED WITH CAUTION." BASED ON THE DATA AVAILABLE, HSC CONCLUDED THAT NO POTENTIAL PRODUCT ISSUE WAS IDENTIFIED WITH THE TSH ASSAY. THE EVENT INVOLVES A PATIENT SPECIFIC ISSUE. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM IS FULLY OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2517506-2022-00112 WAS FILED ON 29-APR-2022. INITIAL MDRS 2517506-2022-00108, 2517506-2022-00109, 2517506-2022-00110, 2517506-2022-00111 AND 2517506-2022-00113 WERE FILED FOR THE SAME EVENT ON 29-APR-2022. MDR SUPPLEMENTS 2517506-2022-00108 SUPPLEMENT 1, 2517506-2022-00109 SUPPLEMENT 1, 2517506-2022-00110 SUPPLEMENT 1, 2517506-2022-00111 SUPPLEMENT 1 AND 2517506-2022-00113 SUPPLEMENT 1 ARE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 0

    A FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM WHICH WAS LATER DETERMINED TO BE DISCORDANT WHEN COMPARED TO THE RESULTS FROM ALTERNATE METHODOLOGIES ON A LATER DATE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED AT A LATER DATE. ON A LATER DATE, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE SIEMENS SYSTEM, AND NON-SIEMENS SYSTEMS AT ALTERNATE FACILITIES AND HIGHER TSH RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) RESULT OR DUE TO THE POTENTIAL CHANGES IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437115 DIMENSION VISTA® DIMENSION VISTA® THYROID STIMULATING HORMONE FLEX® REAGENT CARTRIDGE JLW SIEMENS HEALTHCARE DIAGNOSTICS INC. 10445104 20296BB 00842768015731

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male