BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX W/HM

    MDR report key: 3961950 · Received July 28, 2014

    Report

    Report Number
    1226181-2014-00402
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ADJUSTED SYRINGES ON THE REAGENT PROBE 1 PANEL, REPAIRED LEAKY SAMPLE DRAIN TUBING, AND REPLACED THE HETEROGENEOUS MODULE PUMP HEADS, WASH PUMP TUBING, TUBING FOR REAGENT PROBES 1 AND 2, AND THE TOP SEAL SOLENOID. THE CSE ALSO PERFORMED A MICROCLEAN AND VERIFIED THAT THE INSTRUMENT WAS OPERATIONAL. A SIEMENS TECHNICAL APPLICATIONS SPECIALIST (TAS) VERIFIED THAT THE TROPONIN METHOD ON THE INSTRUMENT IS MEETING SPECIFICATIONS. THE CAUSE OF THE DISCORDANT 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 CUSTOMER CARE CENTER (CCC) TO REPORT THAT DISCORDANT TROPONIN RESULTS HAD BEEN OBTAINED ON A DIMENSION RXL MAX WITH HM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT PHYSICIANS HAD CONTACTED THE LABORATORY AFTER CARDIAC CATHETERIZATIONS WERE PERFORMED ON SIX PATIENTS WHOSE CATHETERIZATION RESULTS SHOWED NO ABNORMALITIES. THE LABORATORY REPEATED PATIENT SAMPLES ON AN ALTERNATE INSTRUMENT AND OBTAINED LOWER TROPONIN RESULTS ON MULTIPLE PATIENT SAMPLES. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437995 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