BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 2884163 · Received December 21, 2012

    Report

    Report Number
    1226181-2012-00170
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MMI
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC DISCUSSED THE MAINTENANCE OF THE INSTRUMENT WITH THE CUSTOMER AND REQUESTED A CHEM WASH PRECISION TEST BE PERFORMED. THE RESULTS INDICATED BIOFILM CONTAMINATION OF THE CHEM WASH FLUIDICS. SIEMENS DISPATCHED A FIELD SERVICE ENGINEER THAT DECONTAMINATED THE SYSTEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS FOR CARDIAC TROPONIN I (CTNI) WAS OBTAINED ON A DIMENSION RXL MAX W/HM INSTRUMENT ON TWO PATIENTS. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND THE CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION RXL MAX WITH HM CLINICAL CHEMSITRY SYSTEM MMI SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1