BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX ANALYZER

    MDR report key: 13928281 · Received March 28, 2022

    Report

    Report Number
    3002807968-2022-00011
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    March 11, 2022
    Report Date
    June 3, 2022
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938011
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOMETER MEDICAL APS HAVE CONCLUDED THEIR INVESTIGATION. MOST LIKELY A BLOOD CLOT GOT LODGED IN VICINITY OF THE REF SENSOR, WHICH HAS DISTURBED THE ELECTRICAL SIGNAL BETWEEN THE REF AND CA, K, NA AND PH SENSORS. FURTHERMORE, PRESENCE OF A CLOT LIKELY HAS CAUSED A DILUTION OF BLOOD SAMPLES WITH RINSE SOLUTION IN THE PH/BG MODULE, RESULTING IN APPROX. 6% HIGHER CL READINGS COMPARED TO ABL90. WHAT WAS DONE TO RESOLVE THE ISSUE: COMPARISON OF THE SAME SAMPLES ON ABL90, PROTEIN REMOVAL PROGRAM PERFORMED, MEASURING CHAMBERS CLEANED AND CHECKED, ADDITIONAL 2-POINT CALIBRATIONS PERFORMED, ADDITIONAL QC PERFORMED.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT A CUSTOMER CALLED TO REPORT THAT AFTER A POTENTIALLY HAEMOLYSED SAMPLE HAD BEEN RUN THROUGH THE ANALYSER THEY HAD FOUR PATIENT RESULTS WHICH GAVE ABNORMALLY HIGH ELECTROLYTE RESULTS, THE VALUES WERE: K - 7.1, 5.8, 6.3 & 8.0 MMOL/L, NA - 230, 224, 233 & 236 MMOL/L, CA - 2.96, 2.45, 2.76 & 2.81 MMOL/L,AND CL - 107, 106, 105 & 104 MMOL/L. REFERENCE VALUES FOR 2 PATIENTS PATIENT 1: K 7.1 MMOL/L DISCREPANT , K 4.3 MMOL/L COMPARISON, NA 230 MMOL/L DISCREPANT , NA 131 MMOL/L COMPARISON, CA 2.96 MMOL/L DISCREPANT , CA 1.21 MMOL/L COMPARISON, CL 107 MMOL/L DISCREPANT ,AND CL 102 MMOL/L COMPARISON. PATIENT 2: K 8.0 MMOL/L DISCREPANT , K 4.9 MMOL/L COMPARISON, NA 236 MMOL/L DISCREPANT , NA 135 MMOL/L COMPARISON, CA 2.81 MMOL/L DISCREPANT , CA 1.19 MMOL/L COMPARISON, CL 104 MMOL/L DISCREPANT ,AND CL 98 MMOL/L COMPARISON. NO REPORTS OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337132 ABL800 FLEX ANALYZER ABL800 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-800 05700693938011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown