BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC QDR

    MDR report key: 1971896 · Received January 18, 2011

    Report

    Report Number
    1971896
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 18, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KGI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING HER FIRST BONE DENSITOMETRY. WHEN THE STUDY WAS READ AND INTERPRETED, THE SOFTWARE ALLOWED A COMPARISON TO ANOTHER PATIENT'S STUDY. THIS WAS DISCOVERED WHEN THE PATIENT CALLED TO REPORT THAT SHE HAD NOT HAD A PREVIOUS STUDY TO COMPARE WITH. THE STUDY WAS RE-ANALYZED AND THE ERROR FOUND. DEPT IS CURRENTLY IN THE PROCESS OF RE-ANALYZING ALL STUDIES PERFORMED ON THIS EQUIPMENT TO BE SURE SAME OR SIMILAR ERROR DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLOGIC QDR BONE DENSITOMETER KGI HOLOGIC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR