BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3020312 · Received March 25, 2013

    Report

    Report Number
    1226181-2013-00143
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    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 AND INSTRUMENT DATA, THE CSE DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CSE INSTRUCTED THE CUSTOMER TO CENTRIFUGE THE SAMPLE ACCORDING TO THE TUBE MANUFACTURER SPECIFICATIONS, WHICH THE CUSTOMER DID. THE SAMPLE WAS THEN RUN, AND RESULTED AS EXPECTED. THE CSE DISCUSSED SAMPLE HANDLING WITH THE CUSTOMER, AND THE CUSTOMER IS NOW ALLOWING THE SAMPLES TO CLOT FOR A MINIMUM OF THIRTY MINUTES BEFORE CENTRIFUGING, AS THE PACKAGE INSERT INDICATES. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS IS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION RXL MAX WITH HM INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN ON AN ALTERNATE INSTRUMENT, AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121574 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1