BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION®

    MDR report key: 13025151 · Received December 17, 2021

    Report

    Report Number
    2517506-2021-00335
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    November 27, 2021
    Report Date
    December 17, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING DISCORDANT FALSELY DEPRESSED SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS ON A DIMENSION EXL W/LM SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE FALSELY DEPRESSED RESULTS. HSC REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND INSTRUMENT DATA FILES. A SIEMENS CUSTOMER SUPPORT ENGINEER (CSE) PERFORMED INSTRUMENT CHECKS AND TESTS TO VERIFY THE INSTRUMENT HARDWARE. NO ERRORS WERE FOUND DURING SYSTEM CHECKS. THE MAINTENANCE PERFORMED BY THE CSE WAS PART OF NORMAL TROUBLESHOOTING FOR EVENTS OF THIS NATURE. SYSTEM VERIFICATION INDICATES ACCEPTABLE PERFORMANCE AFTER THE SERVICE VISIT. NO OTHER ISSUES HAVE BEEN REPORTED BY THE CUSTOMER SINCE THE SERVICE VISIT. THE CAUSE OF THE EVENT IS UNKNOWN. A POTENTIAL PRODUCT ISSUE HAS NOT BEEN IDENTIFIED. THE SYSTEM IS FULLY OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 0

    DISCORDANT, FALSELY DEPRESSED SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON A SINGLE PATIENT SAMPLE ON A DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. THE SAME SAMPLE WAS REPROCESSED ON THE SAME INSTRUMENT. THE RESULTS WERE HIGHER THAN THE DISCORDANT RESULT AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS GIVEN A POTASSIUM INFUSION AND ADMITTED TO THE HOSPITAL. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS OR THE POTASSIUM INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926052 DIMENSION® DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION® EXL¿ WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown