BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 9980194 · Received April 21, 2020

    Report

    Report Number
    3002807968-2020-00014
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 31, 2020
    Report Date
    May 25, 2020
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938004
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INVESTIGATION PERFORMED IT WAS IDENTIFIED THAT THE LOW PH MEASUREMENT WAS DUE TO A BLOOD CLOT UNDER THE PH ELECTRODE.

    Description of Event or Problem · 1

    ON (B)(6) 2020 A CUSTOMER MEASURED A PATIENT SAMPLES ON AN ABL800 ANALYZER WHERE THE PH MEASUREMENT RESULTS WERE FALSE LOW. AT THE MEASUREMENT TIME, THE CUSTOMER DID NOT NOTICE BUT DUE TO THE CONTINUOUS LOWER PH VALUES, THEY NOTICED SOMETHING WERE WRONG. AT LEAST, SAMPLE ID (B)(4) WERE LOWER THAN THE DOCTOR'S EXPECTATION AND DID NOT MATCH THE PATIENT'S CONDITION. THE DOCTOR WAS EXPECTED THE PATIENT TO HAVE PH VALUES IN THE NORMAL RANGE. NO COMPARISON MEASUREMENTS ARE AVAILABLE. SAMPLE ID (B)(4): (B)(6) 2020 10:16 - 7.331, (B)(6) 2020 09:40 - 7.310, (B)(6) 2020 09:31 - 7.370, (B)(6) 2020 09:26 - 7.261, (B)(6) 2020 09:22 - 7.187, (B)(6) 2020 09:11 - 7.256, (B)(6) 2020 08:56 - 7.161, (B)(6) 2020 08:35 - 7.126, (B)(6) 2020 08:24 - 7.151, (B)(6) 2020 07:50 - 7.238. THE PATIENT WAS INCORRECTLY TREATED BASED ON THESE FALSE LOW VALUES. FORTUNATELY, THE TREATMENT HAD NO SERIOUS OUTCOME FOR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445622 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800 05700693938004

    Patients

    Seq Age Sex Outcome Treatment
    1