BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTLAB

    MDR report key: 1812922 · Received August 16, 2010

    Report

    Report Number
    1058332-2010-00001
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Report Date
    April 6, 2010
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    JQP
    Removal / Correction Number
    1058332-08/06/2010-006-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED PRODUCTS INCLUDE SOFTLAB VERSIONS 4.0.1.13.3, 4.0.1.8 - 4.0.1.14, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.7. THESE VERSIONS OF SOFTLAB ARE AFFECTED WHEN USED WITH THE SOFTBANK MODULE. METHOD: INSPECTED SOURCE CODE OF PROGRAM.

    Description of Event or Problem · 1

    SOFTLAB ORDER ENTRY DOES NOT USE THE CORRECT TEST DEFINITION SEARCH TO FIND THE BLOOD PRODUCT WHEN MANUALLY ORDERED. THE TEST DEFINITION SEARCH UTILIZED WAS NOT DEFINED ON THE SYSTEM. WHEN A LIKE-PRODUCT IS ORDERED ON AN EXISTING ORDER USING SOFTLAB ORDER ENTRY, THE CORRESPONDING CROSSMATCH IS NOT ORDERED. A CONFIGURATION CHANGE IN SOFTLAB WILL BE IMPLEMENTED TO REMEDY THE PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1