BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX ANALYZER

    MDR report key: 10354623 · Received August 3, 2020

    Report

    Report Number
    3002807968-2020-00030
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 18, 2020
    Report Date
    May 25, 2022
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K041874
    Removal / Correction Number
    3002807968-05182022-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    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

    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.ON MAY 5TH, 2022 RADIOMETER DECIDED TO INITIATE A RECALL WITH RADIOMETER REFERENCE FAN 915-419. THE CORRECTIONN IS TO INSTALL A SOFTWARE VERSION ON ALL ABL800 ANALYZERS WHICH MITIGATES THE ISSUE. PLEASE REFER TO CORRECTION AND REMOVAL REPORT NUMBER (B)(4).

    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

    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 · 1

    THIS INCIDENT IS SIMILAR TO THE ISSUE REPORTED IN 3002807968-2020-00015, WHICH IS FROM THE SAME CUSTOMER AND ON THE SAME ABL800 ANALYZER.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, AT (B)(4) HOSPITAL -EMERGENCY DEPARTMENT, FALSE LOW MEASUREMENT RESULTS FROM AN ABL800 ANALYZER WERE REPORTED FOR THE PARAMETERS NA, CA AND K. THE MEASUREMENTS OBTAINED DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENTS. THE MEASUREMENTS OBTAINED ARE ATTACHED IN PATIENT RESULTS FOR 3002807968-2020-00030 (NO CA MEASUREMENT RESULTS HAS BEEN PROVIDED). CUSTOMER STATED THAT THERE WERE NO ERRORS OR FLAGS PRESENT. WHEN THEY RAN QC POST THE FALSE LOW RESULTS AND ALL PARAMETERS PASSED. THEY CHANGED THE REFERENCE ELECTRODE AND MEMBRANE TO MONITOR THE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822222 ABL800 FLEX ANALYZER ABL800 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown