BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVANCE ANTITHROMBIN

    MDR report key: 24588395 · Received March 13, 2026

    Report

    Report Number
    9610806-2026-00006
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 14, 2026
    Report Date
    April 20, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JBQ
    PMA / PMN Number
    K242952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL 2026-00185755-1-1 ON 13-MAR-2026. ADDITIONAL INFORMATION RECEIVED 13-APR-2026: THE COMPLAINT HAS BEEN INVESTIGATED AT SIEMENS WITH THE FOLLOWING OUTCOME: THE INFORMATION PROVIDED, INCLUDING PRINTOUTS RELATED TO THE REPORTED ANTITHROMBIN MEASUREMENT, WAS THOROUGHLY REVIEWED. NO ABNORMAL BEHAVIOR WAS OBSERVED IN THE REACTION CURVES, AND NONE OF THE RESULTS WERE FLAGGED BY THE SYSTEM. THE PROVIDED BACKUP DATA DID NOT CONTAIN ANY ADDITIONAL RELEVANT INFORMATION. FURTHER INVESTIGATION USING THE PATIENT SAMPLE WAS NOT POSSIBLE, AS THE SAMPLE WAS NO LONGER AVAILABLE. A REAGENT-RELATED CAUSE WAS EXCLUDED, AS QUALITY CONTROL RESULTS WERE WITHIN THE ACCEPTABLE RANGE. DURING A SERVICE VISIT, AIR BUBBLES WERE DETECTED WITHIN THE WET SYSTEM OF THE INSTRUMENT. THE CUSTOMER SERVICE ENGINEER REPLACED THE COMPLETE TUBING OF THE WET SYSTEM. DURING FLUSHING, IT WAS OBSERVED THAT THE WASH STATION OF THE REAGENT PIPETTOR WAS OVERFLOWING, AND A RUBBER STOPPER WAS FOUND OBSTRUCTING THE DRAIN OF THE WASH STATION AND WAS REMOVED. FOLLOWING THESE CORRECTIVE ACTIONS, NO FURTHER AIR BUBBLES WERE OBSERVED. AFTER THE SERVICE INTERVENTION, THE SYSTEM OPERATED WITHOUT FURTHER ABNORMALITIES. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE DISCORDANT RESULT COULD NOT BE DETERMINED. THE SYSTEM WAS RETURNED TO NORMAL OPERATION FOLLOWING REPLACEMENT OF SERVICE PARTS, AND NO PRODUCT-RELATED FINDING WAS IDENTIFIED. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF A FALSELY LOW ATIII RESULT OBTAINED ON ONE PATIENT SAMPLE ON A BCS XP INSTRUMENT. SIEMENS IS INVESTIGATING THE ISSUE. NOTE: THE INNOVANCE ANTITHROMBIN REAGENT IS MARKETED IN THE UNITED STATES UNDER SIEMENS MATERIAL NUMBER (B)(4). THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THE US PRODUCT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED ANTITHROMBIN (ATIII) RESULT WHILE USING INNOVANCE ANTITHROMIN KIT LOT 03784 ON A BCS XP SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). ANOTHER SAMPLE OF THE SAME PATIENT WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT 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 DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568321 INNOVANCE ANTITHROMBIN ANTITHROMBIN II QUANTITATION JBQ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 03784

    Patients

    Seq Age Sex Outcome Treatment
    1