BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 18813101 · Received February 29, 2024

    Report

    Report Number
    2517506-2024-00082
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    February 7, 2024
    Report Date
    February 29, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND REPORTED THAT THE PHOTOMETER SOURCE LAMP DID NOT INITIALIZE ON THE DIMENSION EXL WITH LM. AN OPERATOR TURNED OFF THE INSTRUMENT, OPENED THE THERMAL CHAMBER, AND REMOVED THE MALFUNCTIONED SOURCE LAMP. WHILE ATTEMPTING TO REPLACE THE NEW SOURCE LAMP, CONTENTS OF THE CUVETTES DRIPPED ON THE OPERATOR¿S LAB COAT AND PANTS. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE. DURING THE VISIT, THE CSE REPLACED THE SOURCE LAMP, PERFORMED LAMP CALIBRATION, AND RAN A SYSTEM CHECK AND QUALITY CONTROL (QC), WHICH RECOVERED ACCEPTABLY. AS PER THE DIMENSION EXL 200 DIMENSION EXL WITH LM OPERATOR¿S GUIDE: THE CUVETTES AND THE CONTENTS OF THE CUVETTES MAY PRESENT A BIOHAZARD OR CHEMICAL HAZARD. FOLLOW STANDARD LABORATORY PROCEDURES FOR PROTECTION FROM BIOHAZARDS AND CHEMICALS WHEN PERFORMING MAINTENANCE AND TROUBLESHOOTING PROCEDURES. THE CUSTOMER¿S METHOD IN PERFORMING THE MAINTENANCE ACTIVITY TO RESOLVE THE MALFUNCTIONED PHOTOMETER SOURCE LAMP CONTRIBUTED TO THE EVENT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED LIQUID FROM CUVETTES DRIPPED ONTO AN OPERATOR¿S LAB COAT AND PANTS WHILE THEY WERE TROUBLESHOOTING A PHOTOMETER SOURCE LAMP ERROR ON THE DIMENSION EXL WITH LM INSTRUMENT. AT THE TIME OF FILING THIS REPORT, IT IS UNKNOWN WHETHER THE OPERATOR¿S SKIN CONTACTED THE CONTENTS OF THE CUVETTES. THE CUSTOMER INDICATED THAT THERE WERE NO TEAR OR PUNCTURES ON THE OPERATOR'S SKIN AND THE OPERATOR DID NOT SEEK ANY MEDICAL ATTENTION. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213143 DIMENSION EXL WITH LM DIMENSION EXL WITH LM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown