BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXILAB GENERAL LAB SYSTEM (GENLAB)

    MDR report key: 260068 · Received January 20, 2000

    Report

    Report Number
    2029302-2000-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2000
    Report Date
    January 19, 2000
    Manufacturer
    SUNQUEST INFORMATION SYSTEMS
    Product Code
    JQP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE INTERFACE BETWEEN THE BAYER TECHNICON IMMUNO 1 SYSTEM AND THE SUNQUEST FLEXILAB GENERAL LABORATORY SYSTEM SOFTWARE (GENLAB) WAS DEVELOPED IN THE EARLY 1990'S. IN 1995 BAYER MODIFIED ITS INSTRUMENT SOFTWARE WHICH RESULTED IN INCORRECT DATA COMMUNICATION CAUSING DATA WITH MORE THAN FIVE CHARACTERS TO BE TRUNCATED TO FEWER DELIMITED CHARACTERS AS OUTPUT TO THE SUNQUEST SYSTEM. BAYER ISSUED A TECHNICAL NOTICE (TN9-5729-25) IN 11/1995 TO ALERT USERS OF THE PROBLEM, BUT SUNQUEST DID NOT RECEIVE THE NOTICE. NO PT HARM RELATED TO THE ISSUE WAS REPORTED. THIS REPORT DOES NOT RELATE IN ANY WAY TO THE FUNCTION OF THE SUNQUEST BLOOD BANK/BLOOD DONOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXILAB GENERAL LAB SYSTEM (GENLAB) LABORATORY INFORMATION SYSTEM SOFTWARE JQP SUNQUEST INFORMATION SYSTEMS VERSION 5.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other BAYER TECHNICON IMMUNO 1 SYSTEM.