BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 6510914 · Received April 21, 2017

    Report

    Report Number
    3002807968-2017-00009
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    November 18, 2016
    Report Date
    June 15, 2017
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REINSTALLATION OF SOFTWARE VERSION 6.16 APPARENTLY SOLVED THE PROBLEM. DATA LOGS FROM THE ANALYZER HAVE BEEN RECEIVED BY RADIOMETER FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DATA LOGS SHOWED THAT THE ROOT CAUSE TO THE LOW TBIL RESULTS WAS THAT HBF CORRECTION WAS NOT ENABLED. THE PROBLEM OF LOW TBIL RESULTS DISAPPEARED WITH INSTALLATION OF SW 6.16 WHICH IS PROBABLY BECAUSE THE SW UPGRADE ENABLED HBF CORRECTION. ENABLING OF HBF CORRECTION IS A USER DEFINED SETTING. IN THE ABL800 FLEX OPERATOR'S MANUAL, THE FOLLOWING IS STATED: "THE GUIDELINES FOR SELECTING/DESELECTING HBF CORRECTION ARE AS FOLLOWS: FOR NEONATAL SAMPLES: USE "ENABLED FOR ALL LEVELS". IT IS IMPORTANT TO ENABLE HBF CORRECTION IN ORDER TO OBTAIN CORRECT RESULTS FOR CTBIL, SO2, FO2HB, FMETHB, FCOHB AND FHHB. FOR ADULT SAMPLES: USE "DISABLED" OR "ENABLED FOR LEVELS > 20 %"."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE ABL835 IN THE DELIVERY ROOM (SERIAL NO. (B)(6)) MEASURED THE PARAMETER TBIL APPROXIMATELY 50% LOWER THAN THE ABL835 ANALYZER IN NEONATAL WARD. THE PROBLEMS APPEARED ONLY ON CAPILLARY BLOOD SAMPLES MEASUREMENTS FROM NEONATES AND NO OTHER PARAMETERS WERE AFFECTED. THE NURSES WERE INSTRUCTED NOT TO RUN ANY BILIRUBIN MEASUREMENTS ON THE AFFECTED ANALYZER. NO REPORTS OF DEATH OR SERIOUS INJURY WERE RECEIVED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293460 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO