BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX ANALYZER

    MDR report key: 17688163 · Received September 6, 2023

    Report

    Report Number
    3002807968-2023-00038
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 23, 2023
    Report Date
    January 25, 2024
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693930909
    PMA / PMN Number
    K131988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOMETER INVESTIGATION OF THE PROVIDED DATA LOGS, SUGGESTED THE PRESENCE OF BLOOD CLOTS. HOWEVER, AS NOT ALL DATA WERE MADE AVAILABLE TO RADIOMETER, IT IS DIFFICULT TO ESTABLISH THE PRECISE MEASUREMENT ERROR AND IF SPECIFICATIONS IS MET.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT WAS ESTIMATED.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, SAMPLES WERE MEASURED ON THE ABL90 FLEX ANALYZER (SERIAL NUMBER:(B)(6) WITH THE FOLLOWING MEASUREMENTS ON THE CALCIUM PARAMETER OBTAINED: SAMPLE 1 1) (B)(6) 2023, 19:15 MEASURED ON COMPARISON ABL90 FLEX ANALYZER: 1.55 MMOL/L 2) (B)(6)2023, 19:17 MEASURED ON ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6)): 0.67 MMOL/L SAMPLE 2 3) (B)(6) 2023, 19:16 MEASURED ON COMPARISON ABL90 FLEX ANALYZER: 1.09 MMOL/L 4) (B)(6) 2023, 19:19 MEASURED ON ABL90 FLEX ANALYZER (SERIAL NUMBER: (B)(6)): 0.69 MMOL/L NEITHER TEST PRESENTED ANY ERRORS CODES IN RELATION TO CA. (ONLY THAT RESULTS WERE BELOW REFERENCE RANGE). VERIFIED CALIBRATION AND QC DATA FOR COMPARISON ABL90 FLEX ANALYZER BEFORE, DURING AND AFTER TESTS. NO ERRORS PRESENT FOR CALIBRATION OR QC. VERIFIED CALIBRATION AND QC DATA FOR THE DISCREPANT ABL90FLEX ANALYZER BEFORE, DURING AND AFTER TESTS, NO ERRORS ON CALIBRATION, QC GENERATED ERRORS AS BELOW: - QC A - CA 0.58 - VALUE(S) BELOW STATISTICAL RANGE. - QC B - CA 0.64 - VALUE(S) BELOW STATISTICAL RANGE. \ 1070: SENSOR RESPONSE ERROR - QC C - NOT RUN, CASSETTE REPLACED. SAMPLES WERE RUN ON 3RD BIOMCHEM ANALYSER TO VERIFY RESULTS. BASED ON THESE, THE CUSTOMER HAS REPORTED THE MEASUREMENTS FROM THE ABL90FLEX ANALYZER (SERIAL NUMBER: (B)(6)) AS FALSE LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224635 ABL90 FLEX ANALYZER ABL90 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-090 05700693930909

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown