BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS

    MDR report key: 2781924 · Received October 4, 2012

    Report

    Report Number
    MW5027198
    Event Type
    Other
    Date Received
    October 4, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJY
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL CHEMISTRY AUTOMATED LINE CONTINUES TO HAVE MULTIPLE FAILURES RESULTING IN SIGNIFICANTLY SLOWED TURNAROUND TIME FOR CHEMISTRY TESTS. SIEMENS SERVICE CONTINUES TO PROMISE REPAIRS BUT DOES NOT DELIVER. THE SIGNIFICANT DOWNTIME OF THE STREAMLAB SYSTEM SLOWS OVERALL TURNAROUND TIME FOR CHEMISTRY TESTS AND RESULTS IN SLOWER DIAGNOSES FOR PATIENTS, INCLUDING EMERGENT DIAGNOSES FOR TRAUMA PATIENTS. DATES OF USE: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS STREAMLAB (CLINICAL CHEMISTRY ANALYZER AUTOMATED LINE) JJY SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SIEMENS VISTA CHEMISTRY ANALYZERS