BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH

    MDR report key: 22402251 · Received July 4, 2025

    Report

    Report Number
    2432235-2025-00178
    Event Type
    Malfunction
    Date Received
    July 4, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 12, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CGX
    UDI-DI
    00630414596457
    PMA / PMN Number
    K161494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 2432235-2025-00178 WAS INITIALLY FILED ON 04-JUL-2025. ADDITIONAL INFORMATION (17-JUL-2025): SIEMENS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA FILES, AND THE INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER OBSERVED LOW QUALITY CONTROL (QC) RESULTS WHEN USING CREA_2 REAGENT LOT 242376 WELL 0, WHILE THE QC RESULTS WERE ACCEPTABLE WITH WELL 1 OF THE SAME LOT. A LOT CALIBRATION WAS PERFORMED, WHICH PRODUCED LOW CALIBRATOR VALUES, ALTHOUGH THE QC RESULTS REMAINED WITHIN THE EXPECTED RANGE. THE DEPRESSED PATIENT RESULTS WERE ASSOCIATED WITH THE AFFECTED REAGENT WELL. SIEMENS RECOMMENDED THAT THE CUSTOMER PERFORM A PACK CALIBRATION INSTEAD OF A LOT CALIBRATION WHILE ADDRESSING QC ISSUES ON A NEW WELL. BASED ON THE INFORMATION AVAILABLE, THE ISSUE WAS ATTRIBUTED TO A COMPROMISED REAGENT WELL, THOUGH THE EXACT CAUSE OF THE INITIAL LOW QC RECOVERY COULD NOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL, AND THE ISSUE WAS RESOLVED BY RECALIBRATION AND SWITCHING TO A NEW REAGENT LOT. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. QUALITY CONTROL (QC) RESULTS WERE WITHIN RANGE WHEN THE ERRONEOUS RESULT WAS OBTAINED. THE CUSTOMER RAN QC AFTER ERRONEOUS RESULT WAS OBTAINED, WHICH RECOVERED OUTSIDE (LOW) THE LABORATORY-ESTABLISHED REFERENCE RANGES ON THE EVENT DATE. SIEMENS IS EVALUATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) PATIENT SAMPLE RESULT ON AN ATELLICA CH 930 ANALYZER. THE INITIAL ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULT RECOVERED HIGHER, MATCHED THE RESULT THAT WAS OBTAINED WHEN REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER, AND WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052376 ATELLICA CH ATELLICA CH CREATININE_2 (CREA_2) CGX SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 242376 00630414596457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown