BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SAMPLE HANDLER PRIME

    MDR report key: 23744920 · Received December 8, 2025

    Report

    Report Number
    2432235-2025-00310
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 10, 2025
    Report Date
    April 2, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K161954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2025-00310 ON 08-DEC-2025. ADDITIONAL INFORMATION (01-APR-2026): SIEMENS FURTHER EVALUATED THE EVENT AND CONCLUDED THAT THE ATELLICA SAMPLE HANDLER PRIME (SHP) WAS CONNECTED TO ATELLICA CH 930 ANALYZER THAT WAS EXPOSED TO FIRE. THE SHP WAS DAMAGED BY HEAT. THE FIRE DID NOT START IN THIS INSTRUMENT. THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES IN SECTION H6 WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION INTO THIS INSTRUMENT IS REQUIRED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT AN ATELLICA SAMPLE HANDLER PRIME WAS DIRECTLY AFFECTED BY FIRE. THIS LED TO THE LOSS OF FUNCTIONALITY ON THE ATELLICA SAMPLE HANDLER PRIME. THE CUSTOMER HAS COMPLETED AN INVESTIGATION OF THE EVENT AND HAS GENERATED A REPORT OF THE FINDINGS. SIEMENS HAS REQUESTED A COPY OF THE REPORT BUT HAS NOT RECEIVED A COPY OF THE REPORT AND HAVE NO AWARENESS OF ITS CONTENTS. ADDITIONALLY, SIEMENS HAS REQUESTED THE OPPORTUNITY TO EXAMINE THE INSTRUMENT BUT HAS NOT BEEN PERMITTED ONSITE TO INVESTIGATE. SIEMENS WILL CONTINUE TO AWAIT THE RECEIPT OF THE INVESTIGATION REPORT AND RESPONSE TO REQUESTS FOR ACCESS TO THE INSTRUMENT FOR INVESTIGATION.

    Description of Event or Problem · 0

    AN OUTSIDE THE UNITED STATES CUSTOMER REPORTED AN ATELLICA SAMPLE HANDLER PRIME WAS DIRECTLY AFFECTED BY FIRE. THERE WERE NO INJURIES REPORTED. THERE WAS NO DELAY IN PATIENT TESTING REPORTED AS THIS FACILITY IS A FORENSIC LABORATORY. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142716 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 NA Unknown