BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX ANALYZER

    MDR report key: 14914197 · Received July 5, 2022

    Report

    Report Number
    3002807968-2022-00024
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 18, 2022
    Report Date
    July 27, 2022
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693930909
    PMA / PMN Number
    K092686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RADIOMETER INVESTIGATION HAS FOUND THAT THE ROOT CAUSE WAS DUE TO PRE-ANALYTICAL SAMPLE PREPARATION, WHERE THE SAMPLE WAS NOT HOMOGENEOUS. THIS LED TO THE REPORTED DISCREPANT RESULTS. HENCE THE ABL90 FLEX ANALYZER WAS FOUND TO HAVE NOT FAILED.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, ON (B)(6) 2022 A SAMPLE WAS MEASURED ON THE ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(4)) AND THE FOLLOWING MEASUREMENTS WERE OBTAINED ON THE SODIUM (NA) PARAMETER: 21:38 138 MMOL/L, 21:39 121 MMOL/L, 22:22 107 MMOL/L, 22:24 107 MMOL/L. A CONTROL IONOGRAM WAS CONDUCTED WITH THE SAMPLE AND THE FOLLOWING MEASUREMENT WAS OBTAINED ON THE SODIUM (NA) PARAMETER: 137 MMOL/L (COMPARISON MEASUREMENT). BASED ON THESE MEASUREMENTS, THE CUSTOMER REPORTED THE LAST 3 RESULTS FROM THE ABL90 FLEX ANALYZER AS FALSE LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480618 ABL90 FLEX ANALYZER ABL90 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-090 05700693930909

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Female