BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA VANCOMYCIN FLEX REAGENT CARTRIDGE

    MDR report key: 20081871 · Received August 27, 2024

    Report

    Report Number
    2517506-2024-00220
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 2, 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 CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ONE ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) PATIENT RESULT OBTAINED ON A DIMENSION VISTA 500 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (20-SEP-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE AVAILABLE INSTRUMENT DATA. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER'S ACCEPTABLE RANGES. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2517506-2024-00220 WAS FILED ON 28-AUG-2024.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE ERRONEOUSLY DEPRESSED SAMPLE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 AND AN ALTERNATE DIMENSION VISTA 500. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. 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
    198202 DIMENSION VISTA VANCOMYCIN FLEX REAGENT CARTRIDGE VANCOMYCIN LEH SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 24102BA 00842768015533

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male