BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX ANALYZER

    MDR report key: 10131925 · Received June 9, 2020

    Report

    Report Number
    3002807968-2020-00021
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 7, 2020
    Report Date
    May 20, 2022
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693938004
    PMA / PMN Number
    K041874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOMETER HAS BEEN ABLE TO PROVOKE SIMILAR SYMPTOMS EXPERIENCED BY THE CUSTOMER AND AS DESCRIBED IN THE COMPLAINT. THE CURRENT HYPOTHESIS IS, THAT INADEQUATE AMOUNT OF SAMPLE UNDER THE REFERENCE, DURING MEASUREMENT IN MICRO MODE, CAUSES DISTURBANCES TO THE LIQUID JUNCTION POTENTIAL AND THEREBY THE ELECTRIC SIGNAL. THIS IS SUSPECTED TO CAUSE FALSELY HIGH- AND LOW MEASUREMENTS OF CCA2+, CNA+ AND CK+. A POSSIBLY AFFECTED PH/BG MODULE HAS BEEN INSTALLED IN AN ANALYZER AT RMED AND FIRST TESTS/MEASUREMENTS HAVE BEEN PERFORMED. IT HAS BEEN POSSIBLE TO EXAMINE THE INTERNAL CHANNELS AND MEASURING CHAMBERS FROM THREE DIFFERENT POSSIBLY AFFECTED ANALYZERS. THE INTERNAL VOLUMES HAVE BEEN CALCULATED AND COMPARED TO NOMINAL VOLUME, WHICH REVEALED NO SIGNIFICANT DIFFERENCE AND THEREBY REMOVING THE SUSPICION OF THE MEASUREMENT CHAMBER AS A STANDALONE ROOT-CAUSE. MORE TESTS WITH A POSSIBLY AFFECTED PH/BG MODULE IS NEEDED, AND THE INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 0

    IT HAS BEEN POSSIBLE TO REPRODUCE DISCREPANT MEASUREMENTS IN MICROMODE. HOWEVER, RADIOMETER CANNOT REPRODUCE DEVIATIONS TO THE EXTENT OBSERVED IN THIS CASE. A TOTAL OF 160 MICROMODE MEASUREMENTS ON WHOLE BLOOD WERE PERFORMED ON FIVE ANALYZERS IN RADIOMETER'S LABORATORY. THE CONCLUSION OF THE ANALYSIS IS THAT THE DEVIATING MEASUREMENTS ARE CAUSED BY A DESIGN ERROR; A COMPROMISED SALT BRIDGE (LIQUID CONNECTION) BETWEEN THE REFERENCE ELECTRODE AND MEASURING ELECTRODES AND BY ERRORS IN THE FLUID TRANSPORT CONTROL PROGRAM FTCP (SW). THE ROOT CAUSE IS DETERMINED AS SOFTWARE DESIGN ERROR.

    Additional Manufacturer Narrative · 0

    FROM THE INVESTIGATION RADIOMETER HAS COMPLETED UNTILL NOW, IT HAS BEEN FOUND THAT THE ISSUE ARISES DUE TO INADEQUATE FILLING OF THE REFERENCE CHAMBER DURING MEASUREMENT OF PATIENT SAMPLES IN MICROMODE. THE ROOT CAUSE IS STILL UNKNOWN AND THE INVESTIGATION WILL CONTINUE TO FOCUS ON IDENTIFYING THE CAUSE FOR THE INSUFFICIENT BLOOD VOLUME IN THE REFERENCE CHAMBER IN MICROMODE MEASUREMENTS. ALL H6 CODES HAVE BEEN UPDATED TO MATCH THE NEW LAYOUT OF THE MEDWATCH FORM IN ESUBMITTER.

    Additional Manufacturer Narrative · 0

    RADIOMETER VISITED THE CUSTOMER BOTH 2020-06-09 AND 2020-08-13 TO PERFORM TROUBLESHOOTING AND INVESTIGATE THE EVENT. AT THE LATEST VISIT THE FOLLOWING WAS INVESTIGATED: PICTURES WAS TAKEN OF PH SEALING RING ON THE ELECTRODE, AND OF GREY TUBING BETWEEN PH/BG AND EL/MET MODULE. FLOW OF CAP95 AND FLEX MODE WERE FILMED AS WELL. THIS INSTRUMENT SHOWED DEVIATING CA AND NA RESULTS ON CAPILLARY SAMPLES COMPARED TO SYRINGE SAMPLES. ONE FINDING WAS THAT THE PH SEALING RING WAS MOUNTED INCORRECTLY BUT AFTER READJUSTING IT CORRECTLY, DID NOT SHOW CLEAR IMPROVEMENTS ON CALIBRATING QCS. THE CUSTOMER HAS BEEN ASKED TO REPLACE THE MEASURING CHAMBER AND HEATING PLATE AND RETURN IT TO RADIOMETER FOR INVESTIGATION. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    AN INTERNAL REVIEW OF THE CASE WAS INITIATED 22OCT2021, AND IT WAS IDENTIFIED THAT WE IN THE LATEST MDR HAD REPORTED PRELIMINARY INVESTIGATION RESULTS. HOWEVER, THE INVESTIGATION OF THIS ISSUE IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE DATA HAS BEEN UPDATED, AS THIS ISSUE WAS NOT CAUSED BY SOFTWARE ALONE, AS PREVIOUSLY STATED. THE ISSUE HAS BEEN FOUND TO BE CAUSED BY A COMBINATION OF SOFTWARE AND ANALYZER SPECIFIC HARDWARE RELATED TO SAMPLE TRANSPORT. RADIOMETER HAS REVIEWED THIS CASE AGAIN WITH RESPECT TO THE SIZE OF THE REPORTED BIAS, AND CONCLUDED THAT THE MALFUNCTION WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. THIS INCIDENT IS THEREFORE NO LONGER CONSIDERED REPORTABLE.

    Additional Manufacturer Narrative · 1

    SHOULD BE NO INFORMATION.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, A CUSTOMER REPORTS THAT THE DOCTOR REFLECTED OVER A CA RESULT OF 1.55 MMOL/L AND TWO HOURS LATER IT WAS 1.41 MMOL/L. THE DOCTOR DID NOT INTERVENE ON BASIS OF THE HIGH RESULT SO THERE WAS NO MALTREATMENT OF THE BABY IN THIS CASE. THE CUSTOMER EXPECTED THE BABY TO BE IN THE NORMAL RANGE FOR CA. THE CUSTOMER REPORTS THE RESULT OF 1.55 MMOL/L AS FALSE HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598200 ABL800 FLEX ANALYZER ABL800 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-800 05700693938004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown