BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX PLUS ANALYZER

    MDR report key: 11759137 · Received May 3, 2021

    Report

    Report Number
    3002807968-2021-00013
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 3, 2021
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693930923
    PMA / PMN Number
    K160153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FINALIZED RADIOMETER INVESTIGATION OF THE PROVIDED DATA LOGS IDENTIFIED A BLOOD CLOT IN THE MEASUREMENT PATH SITUATED IN THE VICINITY OF THE GLU- AND CL-SENSORS, WHICH MOST LIKELY IS THE ROOT CAUSE OF THE ERRONEOUS GLU-MEASUREMENT.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT A PATIENT MEASUREMENT ON THE ABL90 ON 21-04-2021 AT 22:43 HAS BEEN DETERMINED, THE RESULTS OF THE MEASUREMENT ARE NOT TRUSTED BY THE LABORATORY TECHNICIAN AND THEREFORE THE SAME SYRINGE HAS BEEN DETERMINED AGAIN AT 22:48. FOR SOME PARAMETERS THERE ARE MAJOR DIFFERENCES BETWEEN THE TWO MEASUREMENTS. RESULT OF FIRST MEASUREMENT AT 22:43 ARE: CGLU IS 0.4 MMOL/L, CCL IS 101 MMOL/L, PO2 IS 55.6 MMHG. RESULT OF SECOND MEASUREMENT AT 22:48 ARE: CGLU IS 8.7 MMOL/L, CCL IS 107 MMOL/L, PO2 IS 83.6 MMHG. NO MESSAGES ON THE PRINT STRIP, IT IS NOT CLEAR WHY THIS HAPPENED". BASED ON THE COMPARABLE MEASUREMENTS AT 22:43 AND 22:48 THE CUSTOMER REPORTED THE MEASUREMENTS AT 22:43 AS FALSE LOW. NO REPORTS OF SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656874 ABL90 FLEX PLUS ANALYZER ABL90 FLEX PLUS ANALYZER CHL RADIOMETER MEDICAL APS 393-092 05700693930923

    Patients

    Seq Age Sex Outcome Treatment
    1