BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SAMPLE HANDLER PRIME

    MDR report key: 12135724 · Received July 8, 2021

    Report

    Report Number
    2432235-2021-00174
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 17, 2021
    Report Date
    September 10, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K161954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2021-00174 ON 08JUL2021. ADDITIONAL INFORMATION (01SEP2021): THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND A SIEMENS CUSTOMER SERVICE SPECIALIST (CSS) REVIEWED THE INFORMATION. ALL LOGS DURING THE DAY OF THE EVENT WERE REVIEWED AND THE SAMPLE ID COULD NOT BE FOUND. IT WAS CONFIRMED THAT THE SYSTEM WAS UPDATED TO VERSION 1.25 AND THAT THE ISSUE HAD NOT REOCCURRED. SYSTEM WAS FULLY OPERATIONAL. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    TROPONIN, FREE THYROXINE, AND THYROID STIMULATING HORMONE PATIENT SAMPLES WERE DELAYED ON AN ATELLICA SAMPLE HANDLER PRIME. THE SAMPLES WERE UNLOADED INTO THE APTIO OR UNTESTED DRAWERS AND MARKED AS PENDING (PND) IN THE CENTRALINK. IT WAS REPORTED THAT A TROPONIN SAMPLE RESULTED 2 HOURS LATER AND THAT PATIENT CARE WAS IMPACTED BY THE DELAY OF THE MULTIPLE ASSAYS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032361 ATELLICA SAMPLE HANDLER PRIME ATELLICA SAMPLE HANDLER PRIME JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME 00630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1