BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA AUTOSLIDE SYSTEM

    MDR report key: 5783785 · Received July 11, 2016

    Report

    Report Number
    2432235-2016-00369
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 21, 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. FILED THE INITIAL MDR (2432235-2016-00369) ON JULY 11, 2016. SEPTEMBER 23, 2016, ADDITIONAL INFORMATION: 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. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

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

    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 CORRECT PATIENT NAME BUT WITH THE PATIENT SAMPLE IDENTIFICATION (SID) NUMBER FOR THE SUBSEQUENT GLASS SLIDE. THE SUBSEQUENT GLASS SLIDE HAD THE CORRECT PATIENT NAME BUT NO SID NUMBER. NO INCORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). 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
    437770 ADVIA AUTOSLIDE SYSTEM ADVIA AUTOSLIDE SYSTEM KPA SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA AUTOSLIDE SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1