BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH ALBUMIN BCP (ALBP)

    MDR report key: 21029236 · Received December 27, 2024

    Report

    Report Number
    2432235-2024-00364
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    December 10, 2024
    Report Date
    February 10, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CJW
    UDI-DI
    00630414595825
    PMA / PMN Number
    K222116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING ERRONEOUSLY DEPRESSED RESULTS WITH ALBUMIN BCP (ALBP) ON THREE (3) PATIENTS ON AN ATELLICA CH 930 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (13-JAN-2025): SIEMENS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE AVAILABLE INFORMATION PROVIDED BY THE CUSTOMER. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S LABORATORY RANGES AT THE TIME OF THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2024-00364 WAS FILED ON 27-DEC-2024.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY DEPRESSED ALBUMIN BCP (ALBP) RESULTS ON THREE (3) PATIENT SAMPLES WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. TWO OF THE PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED ALBUMIN BCP (ALBP) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730973 ATELLICA CH ALBUMIN BCP (ALBP) ALBUMIN CJW SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 140205 00630414595825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown