BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 20210770 · Received September 13, 2024

    Report

    Report Number
    3002807968-2024-00056
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 28, 2024
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938004
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RADIOMETER INVESTIGATION IS CONCLUDED AND HAS TRACED THE CAUSE BACK TO THE USER. THIS INCIDENT IS THEREFORE NO LONGER CONSIDERED REPORTABLE.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT THE CUSTOMER EXPERIENCED FREQUENT PH PATIENT RESULT ISSUES (MEASUREMENTS UNSTABLE). THIS IS AN ISSUE OCCURRING WITH TWO ABL800 ANALYZERS ((B)(6)) WITH PH ELECTRODE (PART 945-614) INSTALLED AT THE SAME LOCATION. THE ERROR FIRST OCCURRED ON (B)(6) 2024. SINCE (B)(6) 2024, THERE HAVE BEEN 3 OCCURRENCES OF THE SAME ISSUE, BUT ALL WERE RESOLVED BY REPLACING THE PH ELECTRODE. FINALLY, THE ELECTRODE WAS REPLACED ON (B)(6) 2024, AND THE ERROR HAS RECURRED SINCE EARLY AUGUST. THIS REPORT IS FOR (B)(4). SAMPLE / PATIENT ID, MEASUREMENT TIME AND DATE, PARAMETER RESULT, DISCREPANT, MEASUREMENT, ANALYZER S/N; (B)(6), 08:34 (B)(6) 2024, PH 7.539, X, (B)(6); 08:40 (B)(6) 2024, PH 7.529 , X, (B)(6); 09:02 (B)(6) 2024, PH 7.522, (B)(6). (B)(6), 07:28 (B)(6) 2024, PH 7.402, X, (B)(6). 07:34 (B)(6) 2024, PH 7.409, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564249 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800 05700693938004

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female