BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERICHROM ANTITHROMBIN III (A)

    MDR report key: 20505976 · Received October 22, 2024

    Report

    Report Number
    9610806-2024-00043
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 22, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JPE
    UDI-DI
    00842768013461
    PMA / PMN Number
    K933125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY DEPRESSED BERICHROM ATIII PATIENT RESULT ON A SYSMEX CS-5100 INSTRUMENT. SIEMENS EVALUATED THE ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: BASED ON THE AVAILABLE INFORMATION, NO GENERAL SOFTWARE, ASSAY OR SYSTEM ISSUE COULD BE IDENTIFIED. THE ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. SYSMEX CS-5100 BERICHROM ATIII IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DEPRESSED BERICHROM ANTITHROMBIN III (BERICHROM ATIII) RESULT THAT WAS OBTAINED ON A SYSMEX CS-5100 INSTRUMENT. THE INITIAL RESULT WAS REPORT TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL SYSMEX CS-5100 AND THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED BERICHROM ATIII RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947776 BERICHROM ANTITHROMBIN III (A) ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY JPE SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N/A 02557 00842768013461

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Female