BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQECG

    MDR report key: 1702262 · Received May 17, 2010

    Report

    Report Number
    2081230-2010-00001
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Date of Event
    March 30, 2010
    Report Date
    May 14, 2010
    Manufacturer
    BRENTWOOD MED TECHNOLOGY DBA MIDMARK DIAGNOSTICS GROUP
    Product Code
    DSI
    PMA / PMN Number
    K955023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IQECG SOFTWARE IS DESIGNED TO CALCULATE THE QTC VALUE UTILIZING BAZETT'S EQUATION FOR PATIENTS (B)(6), AND HODGES EQUATION FOR PATIENTS (B)(6). (B)(6) DETERMINED THAT WHEN THE USER ACCESSES THE QT DETAILS OPTION TO EITHER EDIT OR ACCEPT THE QT INTERVAL, THE IQECG SOFTWARE RECALCULATES THE QTC VALUE USING THE HODGES EQUATION, REGARDLESS OF PATIENT'S AGE, WITHOUT NOTIFYING THE USER. THE HODGES EQUATION RESULTS A LOWER QTC VALUE THAN THE BAZETT'S EQUATION. THE RECALCULATION ONLY OCCURS WHEN THE USER (LIKELY SPECIALIZED PEDIATRIC CARDIOLOGIST) MANUALLY EDITS OR ACCEPTS THE QT. PUBLISHED ARTICLES ON THE QTC SUBJECT SHOW THAT BOTH HODGES AND BAZETT'S EQUATIONS ARE WIDELY USED AND THERE IS DISAGREEMENT ON WHICH EQUATION IS BETTER. THE ARTICLES DISCUSSING THE USE OF QTC IN LONG QT SYNDROME (LQTS) DIAGNOSIS EMPHASIZE THAT QTC MEASUREMENTS SHOULD BE INTERPRETED IN THE CONTEXT OF THE PATIENT'S PERSONAL AND FAMILY HISTORY (BJSM, 2009 43: 657-662) AND THAT MANY PATIENTS COULD BE DIAGNOSED INACCURATELY WITH LQTS IF THE DIAGNOSIS WAS MADE PRINCIPALLY BECAUSE OF A BORDERLINE QTC MEASUREMENT (ANN PEDIATR CARD 2008 VOL 1 ISSUE 1). THESE STATEMENTS ARE CONSISTENT WITH IQECG WARNING STATEMENT, "NOT ALL ECG ABNORMALITIES CAN BE DETECTED BY COMPUTERIZED / AUTOMATED ECG ANALYSIS ALGORITHM. THE SUGGESTED INTERPRETATION, INCLUDING NUMERICAL AND GRAPHICAL RESULTS, SHOULD BE EXAMINED WITH RESPECT TO THE PATIENTS OVERALL CLINICAL CONDITION." (B)(6) CONSULTED WITH EXPERIENCED PEDIATRIC CARDIOLOGISTS WHO OFFER OPINION THAT THE PROBABILITY FOR HARM IS VERY LOW.

    Description of Event or Problem · 1

    USING IQECG SOFTWARE VERSION 8.0.1, THE USER DOUBLE CLICKED ON THE QT VALUE ON THE ECG EDIT SCREEN TO EDIT THE QT INTERVAL. WHEN THE USER DID NOT CHANGE THE QT INTERVAL AND CLICKED "OK", THE QTC VALUE RECALCULATED. THE QTC VALUE CHANGED FROM 423 MSEC TO 397 MSEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IQECG DSI BRENTWOOD MED TECHNOLOGY DBA MIDMARK DIAGNOSTICS GROUP IQECG NONE

    Patients

    Seq Age Sex Outcome Treatment
    1