BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVANCE ANTITHROMBIN

    MDR report key: 13560336 · Received February 18, 2022

    Report

    Report Number
    9610806-2022-00007
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 14, 2022
    Report Date
    March 17, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JBQ
    UDI-DI
    00842768037146
    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). QUALITY CONTROLS (QC) RECOVERED IN RANGE AT THE TIME OF THE EVENT. SIEMENS IS INVESTIGATING THE ISSUE.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2022-00007 ON 18-FEB-2022. ADDITIONAL INFORMATION (21-FEB-2022): THE RESULTS WERE EVALUTED CORRECTLY BY THE SYSMEX CS-2500 SYSTEM SOFTWARE. QUALITY CONTROLS (QC) RECOVERED IN RANGE AND THE ISSUE WAS LIMITED TO ONE PATIENT SAMPLE. COMPARED TO THE NON-SIEMENS ASSAY USED AT THE ALTERNATE LABORATORY, THE INNOVANCE ANTITHROMBIN ASSAY USES AN INCUBATION TIME TO FACILITATE AN INCREASED SENSITIVITY TO HEPARIN BINDING SITE MUTATIONS. SAMPLE SPECIFIC INTERFERENCES CANNOT BE RULED OUT AS A POTENTIAL CAUSE OF THE RESULT DISCREPANCY. THE CAUSE OF THE EVENT IS UNKNOWN. 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 ANTITHROMBIN (AT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2500 SYSTEM USING INNOVANCE ANTITHROMBIN REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS RERUN FOR AT AT AN ALTERNATE LABORATORY, RECOVERING HIGHER. THE HIGHER 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 AT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16668 INNOVANCE ANTITHROMBIN INNOVANCE ANTITHROMBIN JBQ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE ANTITHROMBIN 00406 00842768037146

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female