BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVANCE HEPARIN

    MDR report key: 13691197 · Received March 8, 2022

    Report

    Report Number
    9610806-2022-00012
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 3, 2022
    Report Date
    March 7, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    KFF
    PMA / PMN Number
    K162540
    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). QUALITY CONTROLS (QC) RECOVERED IN RANGE AT THE TIME OF THE EVENT. NO HARDWARE ERRORS OCCURRED AT THE TIME OF THE EVENT AND THE ISSUE WAS LIMITED TO ONE PATIENT SAMPLE. THE HIL ERROR ON BOTH HEPARIN RESULTS IS TRIGGERED WHEN HIL DETECTION IS NOT POSSIBLE. THE LEVEL KINETICS DATA INDICATED A SAMPLE SPECIFIC PROBLEM (FOAM ON THE SAMPLE), WHICH CAUSED AN INSUFFICIENT SAMPLE ASPIRATION AND A FALSELY LOW HEPARIN RESULT. THE CAUSE OF THE EVENT WAS A SAMPLE SPECIFIC ISSUE. THE ATELLICA COAG 360 SYSTEM IS NOT MARKETED IN THE US NOR SIMILAR IN DESIGN TO A SIEMENS PRODUCT REGISTERED IN THE US. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    A DISCORDANT, FALSELY LOW HEPARIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA COAG 360 SYSTEM USING INNOVANCE HEPARIN REAGENT. THE DISCORDANT RESULT WAS FLAGGED WITH A HEMOLYSIS ICTERUS LIPEMIA (HIL) ERROR AND WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR HEPARIN USING THE SAME SYSTEM AND REAGENT, RECOVERING HIGHER. THE REPEAT RESULT WAS ALSO FLAGGED WITH A HIL ERROR. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S), ALTHOUGH IT IS UNKNOWN IF THIS WAS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HEPARIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168327 INNOVANCE HEPARIN INNOVANCE HEPARIN KFF SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE HEPARIN 00379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown