BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX W/HM

    MDR report key: 3950287 · Received July 22, 2014

    Report

    Report Number
    1226181-2014-00394
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 26, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT, THE CSE DISCOVERED THAT QUALITY CONTROLS FOR TROPONIN AND THYROID STIMULATING HORMONE WERE OUT OF RANGE. THE CSE DECONTAMINATED THE INSTRUMENT, REPLACED HETEROGENEOUS MODULE PROBES AND CASSETTE PUMPS, AND PERFORMED ALIGNMENTS. THE CSE ALSO REPLACED A WASTE PUMP THAT HAD FAILED. A SYSTEM CHECK WAS RUN AND PASSED. THE CAUSE OF THE ELEVATED TROPONIN RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) TO REQUEST SERVICE FOR A DIMENSION RXL MAX WITH HM INSTRUMENT. THE CUSTOMER STATED THAT ONE PATIENT SAMPLE TESTED FOR TROPONIN HAD RESULTED HIGH AND THE RESULT WAS REPORTED TO A NURSE, WHO EXPECTED AN ELEVATED RESULT DUE TO THE PATIENT'S CLINICAL HISTORY. MULTIPLE PATIENT SAMPLES WERE LATER TESTED FOR TROPONIN ON THE INSTRUMENT AND RESULTED FALSELY HIGH. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT A CORRECTED REPORT WAS NOT REQUIRED FOR THE RESULT REPORTED TO A NURSE FOR THE SAMPLE TESTED EARLIER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428713 DIMENSION RXL MAX W/HM CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION RXL MAX W/HM

    Patients

    Seq Age Sex Outcome Treatment
    1