BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVANCE(R) ANTITHROMBIN REAGENT

    MDR report key: 2901348 · Received January 8, 2013

    Report

    Report Number
    9610806-2013-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 9, 2012
    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
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY DEPRESSED ANTITHROMBIN RESULTS IS UNKNOWN. THE REAGENT ISSUE IS UNDER INVESTIGATION BY SIEMENS HEALTHCARE DIAGNOSTICS INC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS OF DECREASING QC VALUES FOR INNOVANCE ANTITHROMBIN (AT) WITH RESULTS DECREASING OUT OF ACCEPTANCE RANGES AFTER 24 HOURS. IT IS UNKNOWN IF PATIENT SAMPLES WERE REPORTED. THE CUSTOMER REPORTS THEY HAVE SWITCHED TO TESTING ON AN ALTERNATE INSTRUMENT SYSTEM. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF FALSELY DEPRESSED AT RESULTS. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE FALSELY DEPRESSED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9804 INNOVANCE(R) ANTITHROMBIN REAGENT INNOVANCE(R) ANTITHROMBIN REAGENT JBQ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 41736

    Patients

    Seq Age Sex Outcome Treatment
    1 Other