BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA AUTOSLIDE SYSTEM

    MDR report key: 5820379 · Received July 25, 2016

    Report

    Report Number
    2432235-2016-00412
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    July 13, 2016
    Report Date
    October 14, 2016
    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

    SIEMENS HEALTHCARE DIAGNOSTICS INC. IS INVESTIGATING THE CAUSE OF THE TWO GLASS SLIDES BEING MISLABELED ON THE ADVIA AUTOSLIDE SYSTEM.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (2432235-2016-00412) ON (B)(6), 2016. ON (B)(6), 2016 SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) HAS INVESTIGATED THE MISLABELING OF TWO GLASS SLIDES ON THE ADVIA AUTOSLIDE SYSTEM. THE ANALYZER CENTRAL PROCESSING UNIT (CPU), THE ANALYZER PC, WASTE PUMPS, VALVE 28, AND THE ADVIA AUTOSLIDE PRINTER RIBBON WERE REPLACED AND THE ADVIA AUTOSLIDE RINSE BOTTLE WAS RELOCATED ON THE TABLE. THE SYSTEM PERFORMANCE WAS MONITORED FOR ONE MONTH AND NO FURTHER SLIDE MISLABELING EVENTS OCCURRED. THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    TWO MISLABELED GLASS SLIDES WERE PRODUCED ON THE ADVIA AUTOSLIDE SYSTEM. THE FIRST GLASS SLIDE WAS LABELED WITH THE INCORRECT PATIENT NAME AND INCORRECT PATIENT SAMPLE IDENTIFICATION (SID) NUMBER, WHICH WERE FOR THE SUBSEQUENT GLASS SLIDE. THE SUBSEQUENT GLASS SLIDE HAD NO PATIENT NAME NOR SID NUMBER PRINTED. NO INCORRECT RESULTS WERE REPORTED TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE TWO GLASS SLIDES BEING MISLABELED BY THE ADVIA AUTOSLIDE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471983 ADVIA AUTOSLIDE SYSTEM ADVIA AUTOSLIDE SYSTEM KPA SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA AUTOSLIDE SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1