BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTWARE FOR DIAGNOSIS/TREATMENT

    MDR report key: 7741595 · Received August 1, 2018

    Report

    Report Number
    1061932-2018-01036
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    July 2, 2018
    Report Date
    October 15, 2018
    Manufacturer
    BECKMAN COULTER
    Product Code
    OSN
    Removal / Correction Number
    2050012-0911/2018-013C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP 01: FIELD ACTION (FA-000072-2) WAS INITIATED TO ADDRESS THIS ISSUE. INSTALLATION OF KALUZA VERSION 2.1.1 WILL PREVENT SOFTWARE CRASHES AND RESULT IN PROPER KEYWORD VALUE BEING TRANSMITTED FOR ALL SAMPLES. KALUZA ANALYSIS 2.1.1 CAN BE DOWNLOADED FROM THE BECKMAN COULTER WEBSITE AND NEEDS TO BE INSTALLED ON ALL AFFECTED SYSTEMS. ADDITIONAL INFORMATION HAS BEEN SELECTED. NOTIFICATION AND MODIFICATION HAVE BEEN SELECTED. NUMBER HAS BEEN UPDATED TO REFLECT THE RESPECTIVE INFORMATION FOR THIS EVENT. ADDITIONAL INFORMATION: FA-000072-2 INCLUDES NOTIFICATION TO THE CUSTOMER AND CORRECTION OF THE ISSUE VIA SOFTWARE UPDATE. BEC INTERNAL IDENTIFIER - (B)(4).

    Additional Manufacturer Narrative · 1

    KALUZA 2.0 SOFTWARE IS AN RUO (RESEARCH USE ONLY) PRODUCT; THEREFORE THERE IS NO IMPACT TO PATIENT RESULTS FOR THIS EVENT. HOWEVER, THERE IS A SIMILAR PRODUCT AVAILABLE WHICH IS LABELED FOR CLINICAL USE (IVD), KALUZA C, 10 USER NETWORK EDUCATIONAL LICENSE SOFTWARE KIT (PN: C10580). THE TECHNICAL SUPPORT SPECIALIST CONFIRMED THE PROBLEM FILED THIS COMPLAINT AND ESCALATED THE ISSUE TO THE SOFTWARE ENGINEER. THE PROBLEM WAS CONFIRMED BY THE SOFTWARE ENGINEERING TEAM AND EXTENDS TO ALL RUO LICENSE TYPES AND CLINICAL VERSIONS OF THE STAND-ALONE ANALYSIS SOFTWARE. THE FOLLOWING WAS OBSERVED: WHEN A NEW FILE IS UPLOADED THE KEYWORDS CREATED IN THE CYTOMETER SOFTWARE ARE CORRECTLY UPDATED IN THE INFO PLOTS. THE KEYWORD VALUES ON THE LIS PREVIEW/EXPORT SCREEN NEVER UPDATE AFTER THE TEMPLATE IS FIRST CREATED. THE FIRST VALUES ENTERED ARE ALWAYS DISPLAYED. SECONDARY SAMPLE IDENTIFIERS (IDS) CAN BE INCLUDED AS KEYWORDS AND WOULD BE TRANSMITTED INCORRECTLY; HOWEVER THE PRIMARY SAMPLE ID IS NOT CODED AS A KEYWORD AND WOULD NOT BE IMPACTED. A STOP SHIP (MIA-18-0257-Q) WAS IMPLEMENTED ON 20-JULY-2018 FOR BOTH RUO AND CLINICAL VERSIONS OF THE SOFTWARE. THE ISSUE WAS ESCALATED TO POST MARKET FOR ASSESSMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBLEM WITH KALUZA 2.0 SOFTWARE IN WHICH KEYWORDS ENTERED BY THE CUSTOMER DID NOT PROPERLY TRANSFER TO THE LABORATORY INFORMATION SYSTEM (LIS). THE LIS TEMPLATE SAVES THE KEYWORD INFORMATION OF THE FILE LOADED WHEN THE TEMPLATE WAS CREATED. WHEN A NEW FILE IS DRAGGED IN, THE KEYWORDS ARE NOT UPDATED. CUSTOMERS ARE PLACING INFORMATION NEEDED FOR RESULT CALCULATION AND FILING IN THE SAMPLE ID FIELDS FOR TRANSMISSION TO LIS. THESE FIELDS (SUCH AS CBC, LYMPH %, DILUTION FACTOR, SAMPLE ID, SERIAL #) ARE THEN USED ON LIS TO CALCULATE FINAL PATIENT RESULT. IF A CUSTOMER DOES NOT REALIZE THE FIELDS TRANSMITTED ARE FOR WRONG DATA FILE, THE RESULTS WILL BE INCORRECT. KALUZA 2.0 IS AN RUO (RESEARCH USE ONLY) PRODUCT; THEREFORE THERE IS NO IMPACT TO PATIENT RESULTS FOR THIS EVENT. HOWEVER, THERE IS A SIMILAR PRODUCT AVAILABLE WHICH IS LABELED FOR CLINICAL USE (IVD), KALUZA C, 10 USER NETWORK EDUCATIONAL LICENSE SOFTWARE KIT (PN: C10580).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580108 SOFTWARE FOR DIAGNOSIS/TREATMENT OSN BECKMAN COULTER SWRE KIT,KALUZA C 10 USER NETWORK EDUCATIONAL LICENSE

    Patients

    Seq Age Sex Outcome Treatment
    1