BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVANCE ANTITHROMBIN, HIGH VOLUME

    MDR report key: 18336297 · Received December 15, 2023

    Report

    Report Number
    9610806-2023-00022
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 17, 2023
    Report Date
    December 15, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JBQ
    PMA / PMN Number
    K081769
    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 A SIEMENS CUSTOMER CARE CENTER (CCC). IN THE SYSTEM BACKUP FILES THAT WERE PROVIDED, NO GENERAL SYSTEM ISSUE COULD BE FOUND. QUALITY CONTROLS (QC) RECOVERED IN RANGE AT THE TIME OF THE EVENT. NO ISSUES WERE OBSERVED WITH THE REACTION KINETICS. THE REPETITIONS WERE PERFORMED OUT OF DIFFERENT SAMPLE TUBES THAN THE INITIAL RESULT. THE CAUSE OF THE EVENT IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE INNOVANCE ANTITHROMBIN, HIGH VOLUME REAGENT IS MARKETED IN THE UNITED STATES UNDER MATERIAL NUMBER 10487303. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THIS PRODUCT.

    Description of Event or Problem · 0

    AN ERRONEOUS, FALSELY ELEVATED ANTITHROMBIN (AT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CN-3000 SYSTEM USING INNOVANCE ANTITHROMBIN, HIGH VOLUME REAGENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). A SAMPLE FROM THE SAME SAMPLE ARCHIVE RACK WAS REPEATED FOR AT AND THE AT RESULT RECOVERED LOWER. ANOTHER SAMPLE FROM THE SAME SAMPLE ARCHIVE RACK WAS REPEATED FOR AT AND THE AT RESULT MATCHED THE LOWER RESULT. THREE DAYS LATER, A NEW SAMPLE FROM THE PATIENT WAS COLLECTED AND WAS RUN FOR AT, AGAIN MATCHING THE LOWER RESULTS. THE LOWER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED AT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887016 INNOVANCE ANTITHROMBIN, HIGH VOLUME INNOVANCE ANTITHROMBIN, HIGH VOLUME JBQ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE ANTITHROMBIN, HIGH VOLUME 01696

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male