BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA AUTOSLIDE SYSTEM

    MDR report key: 3952935 · Received July 23, 2014

    Report

    Report Number
    2432235-2014-00479
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KPA
    PMA / PMN Number
    K051693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS INC. SIEMENS DETERMINED THAT THE CAUSE OF THE EVENT IS DUE TO THE USER INTERFACING WITH THE ADVIA AUTOSLIDE SYSTEM. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS INC AND STATED THAT HE WAS INJURED WHILE CLEARING A RACK JAM ON THE ADVIA AUTOSLIDE INSTRUMENT. WHEN THE CUSTOMER PULLED UP THE RACK COVER, HE WAS HIT IN THE TOOTH WITH THE RACK STACKER GUIDE. THE CUSTOMER DID NOT NEED MEDICAL ATTENTION. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER BEING HIT IN THE TOOTH BY THE RACK STACKER GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430583 ADVIA AUTOSLIDE SYSTEM ADVIA AUTOSLIDE SYSTEM KPA SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA AUTOSLIDE SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1