BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH

    MDR report key: 24582543 · Received March 12, 2026

    Report

    Report Number
    2432235-2026-00076
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 12, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    PDJ
    UDI-DI
    00630414220505
    PMA / PMN Number
    K200256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES CUSTOMER CONTACTED SIEMENS AND REPORTED OBSERVATION OF AN ELEVATED ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WHICH WAS DISCORDANT RELATED TO REPEAT TESTING. SIEMENS IS EVALUATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT 150283. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT SAMPLE IN QUESTION. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN BUT IT IS UNKNOWN IF IT WAS QUESTIONED. THE SAME SAMPLE WAS THEN RETESTED ON THE ORIGINAL ANALYZER, WHICH YIELDED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644797 ATELLICA CH ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E) PDJ SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 150283 00630414220505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown