BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX ANALYZER

    MDR report key: 10501143 · Received September 8, 2020

    Report

    Report Number
    3002807968-2020-00037
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 18, 2020
    Report Date
    December 7, 2020
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K092686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PRE-LIMINARY INVESTIGATION PERFORMED IT WAS DISCOVERED THAT TWO CONSECUTIVE MEASUREMENTS WERE REPORTED TO SHOW ELEVATED LEVEL OF SODIUM WHILE OTHER PARAMETERS SUCH AS CA, K, PH, CL AND PCO2 WAS UNCHANGED. THE PHENOMENA WAS OBSERVED ON TWO OCCASIONS. QUALITY CONTROL (QC) AND CALIBRATION LOGS ALONG WITH SYSTEM MESSAGE LOG INDICATE THE SENSOR CASSETTE TO BE FUNCTIONING AS INTENDED. USE OF ANTICOAGULANTS WITH SODIUM CATIONS OR OTHER CONTAMINATIONS WITH A SODIUM NA+ SOURCE ARE POSSIBLE ROOT CAUSES. THE CUSTOMER HAS, HOWEVER, FOLLOWING INFORMED, THAT AS THE SAMPLES WERE HEEL SAMPLES (WHERE 70% ALCOHOL WAS USED FOR CLEANING) THEY DON'T BELIEVE THAT THE CAUSE FOR THE ELEVATED SODIUM RESULTS COULD BE CAUSED BY CONTAMINATION BY ANTICOAGULANTS IN THIS CASE. RADIOMETER HAS ASKED IF THE SENSOR CASSETTE IS AVALAIBLE FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IT HAS NOT BEEN POSSIBLE TO GET THE AFFECTED SENSOR CASSETTE BACK FOR FURTHER INVESTIGATION, SO THE ROOT CAUSE REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE SENSOR CASSETTE ON THE ABL90 FLEX ANALYZER WAS CHANGED. AFTER REPLACING THE SENSOR CASSETTE NO OTHER FALSE HIGH NA MEASUREMENT RESULTS OCCURRED. THE REPLACED SENSOR CASSETTE IS AVAILABLE FOR TESTING. DATALOGS HAVE BEEN COLLECTED FOR THE FURTHER INVESTIGATION. IT HAS NOT BEEN POSSIBLE TO FILL OUT THE 'HEALT EFFECT - IMPACT CODE' IN THE ESUBMITTER SYSTEM. THE CODE SHOULD HAVE BEEN: 'NO HEALTH CONSEQUENCES OR IMPACT'. FURTHERMORE, THE 'COMPONENT CODE' WHEN IT IS KNOWN FROM THE INVESTIGATION, WHICH COMPONENT IS INVOLVED.

    Description of Event or Problem · 1

    ON 2020-08-18 THE CUSTOMER NOTICED THAT A NA MEASUREMENT RESULT WAS 170 MMOL/L ON ABL90 FLEX ANALYZER ((B)(4)) (CAPILLARY, TEST NUMBER 350153, MEASURED 07:56). ALL OTHER RESULTS WERE NORMAL AND NO ERROR CODES WERE PRESENT. ON 2020-08-18 08:05, THE CUSTOMER MEASURED A NEW CAPILLARY SAMPLE ON THE ABL90 FLEX ANALYZER WHERE THE NA MEASUREMENT RESULT WAS NORMAL 140 MMOL/L. ON 2020-08-24, THE CUSTOMER AGAIN NOTICED A SIMILAR HIGH NA MEASUREMENT RESULT OF 177 MMOL/L (CAPILLARY, TEST NUMBER 349068, MEASURED 07:50) ON THE ABL90 FLEX ANALYZER. WHEN MEASURED WITH A NEW SAMPLE AT 07:57 THE NA MEASUREMENT RESULT WAS 146 MMOL/L. THE SENSOR CASSETTE WAS REPLACED ON THE ABL90 FLEX ANALYZER AFTER NO HIGH NA MEASUREMENT RESULTS HAVE BEEN OBSERVED. THE MEASUREMENT RESULTS ARE SUMMARIZED BELOW: (B)(6) 2020, 07:56 (CAPILLARY TEST NUMBER 350153) ABL90 FLEX ((B)(4)): 170 MMOL/L, (B)(6) 2020, 08:05 (CAPILLARY TEST NUMBER UNKNOWN) ABL90 FLEX ((B)(4)): 140 MMOL/L, (B)(6) 2020, 07:50 (CAPILLARY TEST NUMBER 349068) ABL90 FLEX ((B)(4)): 177 MMOL/L, (B)(6) 2020-, 07:57 (CAPILLARY TEST NUMBER UNKNOWN) ABL90 FLEX ((B)(4)): 146 MMOL/L. BASED ON THE SEQUENCE OF MEASUREMENT RESULTS FOR NA, THE CUSTOMER REPORTED THE MEASUREMENT RESULTS OF 170 MMOL/L AND 177 MMOL/L AS FALSE HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965881 ABL90 FLEX ANALYZER ABL90 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-090

    Patients

    Seq Age Sex Outcome Treatment
    1