BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 17709663 · Received September 8, 2023

    Report

    Report Number
    3002807968-2023-00044
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 26, 2023
    Report Date
    October 23, 2023
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938004
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 CORRECTED TO (B)(6) 2023 AS WAS STATED IN B5 DESCRIPTION. THE RADIOMETER INVESTIGATION HAS BEEN COMPLETED AND FOUND THAT THE ROOT CAUSE IS A KNOWN INHERENT RISK OF DEVICE. A CLOT BENEATH THE PH SENSOR WAS SUSPECTED, WHICH WAS CONFIRMED UPON CHECKING THE ANALYZER.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTS THAT PH AND CBASE(B)C IS MEASURING TOO LOW ON ONE PATIENT MEASURED ON THE ABL800 FLEX ANALYZER SERIAL NUMBER: (B)(6) IN INTENSIVE CARE UNIT. THEY DREW A NEW SAMPLE AND MEASURED THE SAMPLE ON THE SAME INSTRUMENT STILL SHOWING LOW PH AND CBASE(B)C RESULTS. THE CUSTOMER TELLS US, THAT THE DEPARTMENT THEREFOR HAS STARTED TREATMENT FOR LOW CBASE(B)C. THE CUSTOMER REPORTS THAT THEY RIGHT AFTER MEASURING THE SECOND LOW SAMPLE ON THE PATIENT IS MEASURING A NEW PATIENT ALSO SHOWING LOW PH AND LOW CBASE(B)C. THEREFORE, THEY REPEAT THE SECOND SAMPLE FROM THE FIRST PATIENT ON ANOTHER ABL IN THE LAB AND THIS RESULT IS PERFECTLY NORMAL. THIS MAKES THE LAB STAFF SUSPECT CLOT UNDER THE PH ELECTRODE, WHICH SHOWS TO BE THE CASE. THEY CLEANED UP THE MEASURING CHAMBER AND ELECTRODE, ON THE ABL IN INTENSIVE CARE UNIT AND REPEAT BOTH PATIENTS FROM WHERE THEY OBTAINED LOW PH AND CBASE(B)C RESULTS. NOW THEY RECEIVED EQUAL RESULTS ON PH AND CBASE(B)C ON BOTH INSTRUMENTS. PATIENT SAMPLE RESULTS FROM THE PATIENT ONE: SAMPLE/ MEASUREMENT TIME AND DATE PARAMETER RESULT UNITS: (B)(6), (B)(6) 2023 AT 9:30,ABL-INT PH 6,791 DISCREPANT. (B)(6), (B)(6) 2023 AT 9:30, ABL-INT CBASE(B)C -27.4 MMOL/L DISCREPANT. (B)(6), (B)(6) 2023 AT 9:37, ABL-INT PH 6,984 DISCREPANT. (B)(6), (B)(6) 2023 AT 9:37, ABL-INT CBASE(B)C -22,6 MMOL/L DISCREPANT. (B)(6), (B)(6) 2023 AT 10:02, ABL-KBA PH 7,437 COMPARISON. (B)(6), (B)(6) 2023 AT 10:02, ABL-KBA CBASE(B)C -0,5 MMOL/L COMPARISON. (B)(6), (B)(6) 2023 AT 12:47,ABL-INT PH 7,488 COMPARISON. (B)(6), (B)(6) 2023 AT 12:47,ABL-INT CBASE(B)C 2,3 MMOL/L COMPARISON. (B)(6), (B)(6) 2023 AT 12:52, ABL-KBA PH 7,486 COMPARISON. (B)(6), (B)(6) 2023 AT 12:52, ABL-KBA CBASE(B)C 1,6 MMOL/L COMPARISON. THE CUSTOMER REPORTED THAT "THEY GAVE THE PATIENT FLUIDS IN ORDER TO TRY TO RAISE THE LOW CBASE(B)C. LUCKILY THEY QUICKLY FOUND OUT THAT THE RESULT WAS WRONG AND THEY STOPPED THE FLUIDS AND A BLOOD SAMPLE DRAWN AFTERWARDS SHOWED THAT THE PATIENT DID NOT SUFFER ANY INJURY FROM THE GIVEN FLUIDS." BASED ON THESE MEASUREMENTS, THE CUSTOMER HAD REPORTED THE PH AND CBASE(B)C MEASUREMENTS OF SAMPLES 42164 AND 42165 FROM THE ABL800 FLEX ANALYZER SERIAL NUMBER: (B)(6) AS FALSE LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243211 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800 05700693938004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown