BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 4100014 · Received September 18, 2014

    Report

    Report Number
    9610806-2014-00024
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    PMA / PMN Number
    K974343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCREPANT FALSELY ELEVATED PT INR RESULTS IS USER ERROR. THE ACCOUNT DID NOT PROPERLY SAVE INPUTS OF THE CORRECT LOT SPECIFIC ISI AND MNPT VALUES DADE INNOVIN LOT IN USE FOR THE PT EXTENDED MODE ASSAY CONFIGURATION (PTX). THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER- TECHNICAL SOLUTIONS REPRESENTATIVE ASSISTED THE ACCOUNT IN REINFORCING THE MANNER OF PROPERLY USING THE CORRECT ISI AND MNPT VALUES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED PROTHROMBIN TIME INR (PT-INR) RESULTS WERE OBTAINED ON PATIENT SAMPLES. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIANS. AN ERROR IN THE SETTINGS FOR THE ISI AND MNPT FACTORS IN THE EXTENDED MODE ASSAY CONFIGURATION (PTX) WAS NOTED AFTER INVESTIGATION BY THE LABORATORY. CALCULATIONS SHOW THAT LOWER RESULTS WOULD BE REPORTED WITH THE CORRECT ISI AND MNPT FACTOR SETTINGS. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED PT-INR RESULTS. THERE IS NO REPORT OF ADVERSE OUTCOME TO PATIENTS AS A RESULT OF THE FALSELY ELEVATED PT-INR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578449 DADE INNOVIN DADE INNOVIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 539264

    Patients

    Seq Age Sex Outcome Treatment
    1