BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA AUTOSLIDE SYSTEM

    MDR report key: 5590552 · Received April 20, 2016

    Report

    Report Number
    2432235-2016-00178
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    March 25, 2016
    Report Date
    October 6, 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 (2432235-2016-00178) ON APRIL 20, 2016. SEPTEMBER 14, 2016, ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) HAS INVESTIGATED THE MISLABELING OF TWO GLASS SLIDES ON THE ADVIA AUTOSLIDE SYSTEM AND HAS DETERMINED THAT THERE ARE NO ISSUES WITH THE PRINTER CONTROL BOARD. SIEMENS HAS DETERMINED THAT THIS IS AN ISOLATED INCIDENT AT THIS CUSTOMER SITE AND IS RECOMMENDING THAT THE ADVIA AUTOSLIDE SYSTEM BE REPLACED AT THIS ACCOUNT DUE TO THE AGE OF THE SYSTEM AND ITS HEAVY USE. 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 NO PATIENT NAME AND 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
    243596 ADVIA AUTOSLIDE SYSTEM ADVIA AUTOSLIDE SYSTEM KPA SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA AUTOSLIDE SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1