BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTLAB

    MDR report key: 2167959 · Received June 16, 2011

    Report

    Report Number
    1058332-2011-00002
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    June 14, 2011
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    JQP
    Removal / Correction Number
    1058332-03/23/2011-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLIENT REPORTED THE PRODUCT MALFUNCTION ON SOFTLAB VERSION 4.0.3.8 USING DORA VERSION 2.0.0.7 WITH HOT FIX 1.6595. AFFECTED PRODUCTS INCLUDE ANY VERSION OF SOFTLAB USING DORA VERSIONS 2.0.0.4 (WITH HOT FIX 1.2808, 1.2809, 1.2956, OR 1.3476), 2.0.0.5, 2.0.0.6, 2.0.0.7 WITH HOT FIX 1.6595, AND 2.1.0.3. METHOD: INSPECTED SOURCE CODE OF PROGRAM.

    Description of Event or Problem · 1

    A LOW LEVEL DATABASE FUNCTION IN A COMPONENT THAT COMMUNICATES INFORMATION BETWEEN SCC APPLICATIONS (SUCH AS SOFTLAB) AND AN ORACLE DATABASE, HANDLES RECOVERY FROM CERTAIN TYPES OF TABLE ACCESS CONFLICTS BY AUTOMATICALLY RETRYING A SERIES OF DATABASE OPERATIONS. SUCH CONFLICTS ARE EXTREMELY RARE BUT WHEN THEY OCCUR, THIS FUNCTION HAS THE POTENTIAL TO CAUSE FAULTY WRITING TO THE DATABASE WHICH COULD RESULT IN PATIENT RESULTS BEING SENT TO THE WRONG PATIENT RECORD. NO ADVERSE PATIENT EVENT IS ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTLAB JQP SCC SOFT COMPUTER

    Patients

    Seq Age Sex Outcome Treatment
    1