BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 10188344 · Received June 24, 2020

    Report

    Report Number
    3002807968-2020-00024
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    May 31, 2020
    Report Date
    February 10, 2021
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FROM THE PRELIMINARY INVESTIGATION PERFORMED IT HAS BEEN FOUND FROM SCREENSHOTS PROVIDED BY THE CUSTOMER, THAT TWO SAMPLES HAD THE SAME SAMPLE NUMBER; #(B)(6). - FIRST SAMPLE AT 20:24H (CORRECT) . -SECOND SAMPLE AT 20:49H (INCORRECT) . BOTH SAMPLES HAVE SAME PATIENT ID AND OPERATOR, ONLY THE MEASUREMENT VALUES DIFFERS. THE SAMPLE RUN AT 20:24H IS MISSING IN THE PATIENT RESULT LOG BUT IT WAS TRANSMITTED TO AQURE. THE OPERATOR OF SAMPLE RUN AT 20:49H SEEMS WRONG. IT SHOULD HAVE BEEN THE OPERATOR WITH THE INITIALS BHAT INSTEAD OF THE OPERATOR WITH THE INITIALS H1SS. RADIOMETER HAS ASKED TO CUSTOMER PROVIDE ADDITIONAL INFORMATION TO PROCEED WITH THE ROOT CAUSE INVESTIGATION

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION MADE IT HAS NOT BEEN POSSIBLE TO REPRODUCE THE PROBLEM IN SW V6.18, WHICH IS USED BY THIS CUSTOMER. FURTHERMORE, RADIOMETER CANNOT EITHER REPRODUCE THE ISSUE IN SW V6.19 MR1, WHICH IT IS THE LATEST MANDATORY SW RELEASED (RELEASED AND REPORTED TO FDA UNDER SECTION 21 USC 360(I), CORRECTION/REMOVAL NUMBER 3002807968-05/14/20-006-C WITH RADIOMETER REF. 915-412). INVESTIGATION OF SW 6.19MR1 CODE CONCLUDES THAT THIS PROBLEM CANNOT OCCUR. A SIMILAR PROBLEM WAS FIXED IN THE LATEST MANDATORY RELEASE IN SW V6.19 MR1, WHY RADIOMETER SUGGEST THAT THE NEW SW WILL ELIMINATE THE PROBLEM REPORTED. THE ROOT CAUSE REMAIN AS UNKNOWN. THIS CUSTOMER WILL ACCORDING TO THE CORRECTIVE ACTION PLAN BE UPDATED TO SW 6.19MR1 NO LATER THAN (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    DATALOGS RETRIEVED FROM ANALYZER FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT TWO DIFFERENT MEASUREMENT RESULTS FROM AN ABL800 ANALYZER ENDED UP WITH SAME SAMPLER ID# AND PATIENT ID#. ACCORDING TO THE FIELD SERVICE ENGINEER, SAMPLE #1 WAS RUN AND THE OPERATOR LOGGED OFF. LATER A NURSE LOGS ON TO THE DEVICE AND RUNS A SECOND SAMPLE. SHE SCANS THE PATIENT'S ID AND THE PATIENT NAME APPEARS ON SCREEN. BUT THE DISPLAY SUDDENLY CHANGES AND BECOMES THE SAME AS THE PREVIOUS SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651183 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800

    Patients

    Seq Age Sex Outcome Treatment
    1