BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SH PRIME

    MDR report key: 24044111 · Received January 12, 2026

    Report

    Report Number
    2432235-2026-00009
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 24, 2025
    Report Date
    January 12, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    630414002439
    PMA / PMN Number
    K161954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DAMAGED SAMPLE ID (SID) BARCODE LABEL WAS MISREAD WHEN LOADED AND SCANNED BY THE ATELLICA SAMPLE HANDLER PRIME (SHP). A SIEMENS REGIONAL SUPPORT SPECIALIST (RSC) INVESTIGATED THE REPORTED ISSUE AND FOUND THAT THE SID BARCODE LABEL WAS DAMAGED / TORN. THE SID LABEL WAS TORN WHEN APPLIED TO THE TUBE AND WAS NOT DAMAGED BY THE ATELLICA SHP. THE SHP WAS CONFIGURED TO ALLOW FOR A BARCODE SYMBOLOGY THAT DOES NOT CONTAIN A CHECK DIGIT. A CHECK DIGIT IS USED TO PREVENT MISREADS. THE SID BARCODE FORMAT IS UNKNOWN. THE CAUSE OF THE MISREAD SID IS DUE TO A USE ERROR OF APPLYING A DAMAGED BARCODE LABEL THAT WAS PRINTED WITH A BARCODE SYMBOLOGY THAT DOES NOT INCLUDE A CHECK DIGIT. THE ANALYZER IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS ANALYZER IS NEEDED.

    Description of Event or Problem · 0

    A DAMAGED SAMPLE ID (SID) BARCODE LABEL WAS MISREAD WHEN LOADED ON AND SCANNED BY THE ATELLICA SAMPLE HANDLER PRIME (SHP). TESTS WERE PERFORMED ON THE MISREAD SID. THE TEST RESULTS WERE NOT RELEASED TO A PHYSICIAN. THE SID BARCODE LABEL WAS REPRINTED, AND THE SAME TUBE WAS RELABELED AND THEN REPROCESSED ON THE SHP. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103084 ATELLICA SH PRIME ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. 11069001 630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown