BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH

    MDR report key: 21824336 · Received April 11, 2025

    Report

    Report Number
    2432235-2025-00108
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 18, 2025
    Report Date
    May 20, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    NQD
    PMA / PMN Number
    K081294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (16-MAY-2025): SIEMENS REVIEWED THE CUSTOMER COMPLAINT REGARDING A LEAKING BOTTLE SEAL/LID UPON RECEIPT OF THE HIGH SENSITIVITY C-REACTIVE PROTEIN SHIPMENT AND DETERMINED THAT IT DOES NOT INDICATE A REAGENT LOT OR METHOD ISSUE. SIEMENS ALSO REVIEWED THE MANUFACTURING RECORDS AND INSPECTED THE AVAILABLE SAMPLES. SIEMENS CONCLUDED THAT THERE WAS NO EVIDENCE OF POTENTIAL PRODUCT NONCONFORMANCE, PROCESS DEVIATION, OR SYSTEMIC ISSUE THAT COULD LEAD TO THE REPORTED PHYSICAL DEFECT WERE IDENTIFIED. THERE WAS NO EVIDENCE OF AN ELEVATED REJECT COUNT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE OF A POTENTIAL PRODUCT ISSUE. THE DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING, AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS. SIEMENS FILED INITIAL MDR 2432235-2025-00108 ON 11-APR-2025.

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT UPON OPENING THE BOX FOR THE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), THEY FOUND THAT THE BOTTLE SEAL/LID HAD LEAKED WHEN THE SHIPMENT WAS RECEIVED FOR THE ATELLICA CH 930 ANALYZER. THE CUSTOMER STATED THAT THE OUTER BOX WAS INTACT AND NO OTHER BOXES IN THE SHIPMENT WERE AFFECTED. SIEMENS IS EVALUATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT UPON OPENING THE BOX FOR THE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), THEY FOUND THAT THE BOTTLE SEAL/LID HAD LEAKED WHEN THE SHIPMENT WAS RECEIVED FOR THE ATELLICA CH 930 ANALYZER. THE OPERATOR NOTED THAT PACK 1 OF ONE WELL CAP WAS SLIGHTLY DEPRESSED, AND FLUID HAD LEAKED FROM THE BOTTLE, AND WAS ABSORBED BY THE BOX, WHICH WAS WET. THE CUSTOMER'S HANDS WERE BRIEFLY EXPOSED TO THE LIQUID MATERIAL WHEN THEY UNPACKED AND OPENED THE BOX. THE CUSTOMER DID NOT WEAR THEIR PERSONAL PROTECTIVE EQUIPMENT (PPE). THE CUSTOMER WASHED THEIR HANDS IMMEDIATELY AFTER EXPOSURE AND DISCARDED THE BOX AND BOTTLE ACCORDING TO THEIR LAB PROCEDURES. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092956 ATELLICA CH ATELLICA CH HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP) NQD SIEMENS HEALTHCARE DIAGNOSTICS INC N/A 242300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown