BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION®

    MDR report key: 7325838 · Received March 8, 2018

    Report

    Report Number
    2517506-2018-00147
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 20, 2018
    Report Date
    May 4, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    UDI-DI
    00842768022067
    PMA / PMN Number
    K081643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL MDR 2517506-2017-00147 WAS FILED 08-MAR-2018. MDRS 2517506-2018-00 00143, 2517506-2018- 00144, 2517506-2018- 00145, 2517506-2018- 00154 AND 2517506-2018- 00155 WERE ALSO FILED FOR THE SAME EVENT. ADDITIONAL INFORMATION (16-APR-2018): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN DIMENSION EXL LOCI (TNI) RESULTS. THERE WAS NO INDICATION OF QUALITY CONTROL BEING OUTSIDE OF LABORATORY RANGES. A SAMPLE FROM THE PATIENT WAS RETURNED TO SIEMENS AND EVALUATED. THE RESULT WITH THE DIMENSION VISTA LOCI CTNI REAGENT CONFIRMED THE ORIGINAL COMPLAINT OF ELEVATED LOCI TNI RESULT. THE SAME SAMPLE GAVE A LOWER RESULT WITH AN ALTERNATE SIEMENS NON-LOCI METHODOLOGY, ADVIA CENTAUR. THE ELEVATED DIMENSION VISTA TNI RESULT REMAINED ELEVATED AFTER TREATMENT WITH A HETEROPHILE BLOCKING AGENT INDICATING THAT THE BLOCKING AGENT DID NOT BLOCK THE INTERFERENCE. THE SAMPLE WAS DILUTED AND DILUTED LINEARLY. THE RESULT OF THIS TESTING DID NOT CONFIRM HETEROPHILIC INTERFERENCE. THE ROOT CAUSE OF PATIENT SPECIFIC INTERFERENT IS UNKNOWN. NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED DURING THE INVESTIGATION. THE DIMENSION VISTA TNI INSTRUCTIONS FOR USE (IFU) STATES IN THE LIMITATIONS OF PROCEDURE: 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. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    MDR 2517506-2018-00143, MDR 2517506-2018-00144, MDR 2517506-2018-00145, MDR 2517506-2018-00154, MDR 2517506-2018-00155 WERE ALSO FILED FOR THE SAME CUSTOMER INQUIRY. THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER FOR THE DISCORDANT ELEVATED CARDIAC TROPONIN I (TNI) RESULTS ON THE DIMENSION EXL INSTRUMENT. QUALITY CONTROL WAS WITHIN SPECIFICATION DURING TESTING. THE CAUSE FOR THE DISCORDANT ELEVATED TNI RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING THE INCIDENT.

    Description of Event or Problem · 1

    DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE RESULTS WERE QUESTIONED WHEN ANOTHER SAMPLE WAS DRAWN FROM THE SAME PATIENT AND A NEGATIVE RESULT WAS OBTAINED BY ALTERNATE NON-SIEMENS METHODOLOGY. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TNI RESULTS OR DUE TO THE CT CORONARY ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166443 DIMENSION® DIMENSION®TNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. EE8179 00842768022067

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR