BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA AUTOSLIDE SYSTEM

    MDR report key: 5890639 · Received August 19, 2016

    Report

    Report Number
    2432235-2016-00496
    Event Type
    Malfunction
    Date Received
    August 19, 2016
    Date of Event
    July 20, 2016
    Report Date
    October 14, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INCL
    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 ON TWO SEPARATE DAYS.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (2432235-2016-00496) ON AUGUST 19, 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.

    Description of Event or Problem · 1

    THE CUSTOMER HAD TWO SEPARATE INCIDENTS THAT OCCURRED ON TWO SEPARATE, SUBSEQUENT DAYS WHERE TWO MISLABELED GLASS SLIDES WERE PRODUCED ON THE ADVIA AUTOSLIDE SYSTEM ON EACH DAY. ON (B)(6) 2016, 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 NOR A SEQUENCE NUMBER PRINTED. NO INCORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). ON (B)(6) 2016, 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 NO PATIENT NAME AND NO SID NUMBER PRINTED. NO INCORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO ERROR MESSAGES THAT WERE LOGGED AROUND THE TIME OF THE EVENTS. 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 ON TWO SEPARATE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543788 ADVIA AUTOSLIDE SYSTEM ADVIA AUTOSLIDE SYSTEM KPA SIEMENS HEALTHCARE DIAGNOSTICS INCL ADVIA AUTOSLIDE SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1