BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 8621377 · Received May 17, 2019

    Report

    Report Number
    2517506-2019-00203
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 17, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K143720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A DISCORDANT, FALSELY DEPRESSED VANCOMYCIN (VANC) RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) COMPLETED THE INVESTIGATION OF THE EVENT. HSC HAS REVIEWED THE INFORMATION PROVIDED AND THE INSTRUMENT DATA. CALIBRATION AND QUALITY CONTROL DATA WERE WITHIN CONFORMANCE. THE CUSTOMER COMPLETED BASIC TROUBLESHOOTING AT THE REQUEST OF THE CUSTOMER CARE CENTER (CCC). THE CUSTOMER DECLINED ADDITIONAL INSTRUMENT HARDWARE SUPPORT. THERE IS NO EVIDENCE OF A PRODUCT NONCONFORMANCE. THE CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT FALSELY DEPRESSED VANCOMYCIN (VANC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS PROCESSED THE SAME DAY AND A HIGHER RESULT WAS OBTAINED AND REPORTED. THE ORIGINAL SAMPLE WAS REPROCESSED IN DUPLICATE ON THE ORIGINAL DIMENSION VISTA AT A LATER DATE AND HIGHER RESULTS WERE OBTAINED. A CORRECTED RESULT WAS REPORTED. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED VANC RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414151 DIMENSION VISTA® DIMENSION VISTA®1500 SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®1500 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1