BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATACARE POC

    MDR report key: 368564 · Received December 21, 2001

    Report

    Report Number
    1823260-2001-00281
    Event Type
    Malfunction
    Date Received
    December 21, 2001
    Date of Event
    November 29, 2001
    Report Date
    December 20, 2001
    Manufacturer
    RDC - ROSWELL
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL DATA MANAGEMENT CONNECTIVITY SOFTWARE FOR DIAGNOSTIC DEVICES - IF AN OPERATOR DOES NOT SAVE OR CLEAR BEFORE RE-ENTERING THE SAMPLE QUEUE A MISMATCH CAN OCCUR BETWEEN SAMPLE DEMOGRAPHIC INFO AND RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58181 DATACARE POC HOSPITAL DATA MGMT CONNECTIVITY SOFTWA JQP RDC - ROSWELL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA