BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 9185138 · Received October 14, 2019

    Report

    Report Number
    3002807968-2019-00047
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    August 26, 2019
    Report Date
    July 21, 2020
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D10 AND H6 HAS BEEN UPDATED AS RADIOMETER HAS RECEIVED DATA LOGS FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT RELATES TO TWO OTHER INCIDENTS, REPORTED AS 3002807968-2019-00046 AND 3002807968-2019-00048.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, CUSTOMER SAMPLES FROM A PATIENT WERE MEASURED ON AN ABL800 FLEX ANALYZER WITH THE FOLLOWING RESULTS FOR NA+ AND CA2+: (B)(6) 2019 / 22:58 (MEASUREMENT TIME) / NA+: 166 MMOL/L / CA2+: 1.77 MMOL/L. LAB RESULTS FOR COMPARISON: (B)(6) 2019 / 01:30 (MEASUREMENT TIME) / NA+: 139. BASED ON THE SERIES OF MEASUREMENTS, THE CUSTOMER REPORTS THE RESULT OF 166 MMOL/L FOR NA+ AS FALSE HIGH. NO COMPARISON RESULTS FROM THE LAB WERE RECEIVED FOR CA2+, BUT THE CUSTOMER ALSO REPORTS THE CA2+ RESULT AS FALSE HIGH. THE CUSTOMER HAS REPLACED THE REFERENCE MEMBRANE, AND AFTER THIS NO MORE FALSE HIGH RESULTS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982722 ABL800 FLEX ABL800 FLEX CHL RADIOMETER MEDICAL APS 393-800

    Patients

    Seq Age Sex Outcome Treatment
    1