BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 19536134 · Received June 14, 2024

    Report

    Report Number
    2517506-2024-00165
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 25, 2024
    Report Date
    June 14, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LEH
    UDI-DI
    00842768015533
    PMA / PMN Number
    K061655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) RESULT ON A PATIENT SAMPLE OBTAINED ON A DIMENSION VISTA 500 SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE AVAILABLE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. CALIBRATION WAS ACCEPTABLE AND WITHIN SPECIFICATIONS. THERE WERE NO PROCESS ERRORS AND NO DIMENSION VISTA 500 SYSTEM PERFORMANCE ISSUES. QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE CUSTOMER¿S EXPECTED RANGES, AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES, INDICATING THAT THE VANC ASSAY WAS PERFORMING ACCEPTABLY. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) RESULT ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM WHEN THE SAMPLE WAS REPROCESSED. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 SYSTEM. A HIGHER REPROCESSED RESULT WAS OBTAINED, CONSIDERED CORRECT, MATCHED THE PRIOR INITIAL RESULT OBTAINED FOR THE SAME SAMPLE, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391237 DIMENSION VISTA® DIMENSION VISTA® VANCOMYCIN FLEX® REAGENT CARTRIDGE LEH SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 23360BA 00842768015533

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male