BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL

    MDR report key: 20477609 · Received October 17, 2024

    Report

    Report Number
    3006543086-2024-00003
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    September 9, 2024
    Report Date
    October 17, 2024
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    UDI-DI
    15099590748036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER TECHNICAL SUPPORT (CTS) PROVIDED THAT THE CUSTOMER RELEASED THE INCORRECT DIFFERENTIAL RESULTS FROM THE REMISOL BEFORE THE BLOOD FILM WAS COMPLETED. THE CUSTOMER SHOULD HAVE CONFIRMED IF THERE IS A DIFFERENCE BETWEEN WHAT THE ANALYZER AUTOMATICALLY CALCULATED AND WHAT THEY SAW FROM A MANUAL DIFFERENTIAL. CTS CONFIRMED THAT THE REMISOL HAS NOT MISCALCULATED OR RELEASED ERRONEOUS RESULTS. THE CUSTOMER HAS NOT BEEN FOLLOWING THEIR WORKFLOW TO COMPLETE THE BLOOD FILM BEFORE RELEASING THE RESULTS FROM REMISOL. QA INVESTIGATOR FOLLOWED UP WITH THE CTS ON (B)(6)2024, AND THE CUSTOMER PROVIDED THAT THE CHANGE IN NEUTROPHIL COUNT FROM (B)(4) AFTER THE BLOOD FILM WAS REVIEWED. THE CUSTOMER FURTHER CLARIFIED THAT THE CLINICAL TEAM GAVE IV ANTIBIOTICS FOR THE PATIENT WITH CHEST INFECTION. PATIENT HAD IV ANTIBIOTICS INSTEAD OF ORAL ANTIBIOTICS IN 24 HOURS. PATIENT WAS SWITCHED TO ORAL ANTIBIOTICS WHEN FINAL NEUTROPHIL COUNT WAS REPORTED. THERE WAS NO REPORT OF HARM TO PATIENT. CTS NOTED THAT THE REMISOL WAS SET UP TO HOLD AND NOT AUTOVALIDATE/RELEASE THE DIFFERENTIAL RESULTS TO THE LIS (LABORATORY INFORMATION SYSTEM) AND FURTHER OUT TO CLINICIANS UNTIL THE CUSTOMER HAVE REVIEWED THE BLOOD FILM. THE CUSTOMER HAS BEEN MANUALLY RELEASING/VALIDATING THE RESULTS FROM REMISOL BEFORE THE REVIEWING BLOOD FILM. THE FAILURE MODE IS DUE TO THE CUSTOMER NOT FOLLOWING THEIR LABORATORY-SPECIFIC WORKFLOW TO COMPLETE THE BLOOD FILM BEFORE RELEASING THE RESULTS FROM REMISOL. THERE IS NO EVIDENCE OF A REMISOL SYSTEM MALFUNCTION. THE CUSTOMER WAS INSTRUCTED TO REVIEW THE BLOOD FILM BEFORE RELEASING THE DIFFERENTIALS. THE CUSTOMER REQUESTED TO SET UP THE RULE TO AUTOMATICALLY ADDS A BLOOD FILM (FR OR FRC TEST CODES ON WINPATH (SOFTWARE APPLICATION)), REMOVE THE NUMERICAL VALUES ON 5-PART WBC (WHITE BLOOD CELL) DIFFERENTIAL (NEUT (NEUTROPHIL), LYMPH (LYMPH NODES), MONO (MONONUCLEOSIS), EOS (EOSINOPHIL, BASO (BASOPHIL)), AND REPLACE THE NUMERICAL VALUES WITH ¿MANUAL DIFFERENTIAL PENDING' TO RESOLVE THE ISSUE. NO FURTHER ISSUES WERE REPORTED AND THE CUSTOMER IS SATISFIED. SECTION A2, A4 AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. SECTION E1, INITIAL REPORTER TELEPHONE NUMBER IS (B)(6). SECTION G1, REPORTING CONTACT US PHONE NUMBER: (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    ON (B)(6)2024, THE CUSTOMER REPORTED THAT THEY HAD SEVERAL INCIDENTS WHERE AN INCORRECT MANUAL DIFFERENTIAL WAS RELEASED BEFORE THE FINAL BLOOD FILM WAS REPORTED. ON (B)(6)2024, THE CUSTOMER CONFIRMED THAT INCORRECT PATIENT RESULTS WERE RELEASED OUT OF THE LABORATORY. THE INCORRECT METHOD OF TREATMENT WAS PROVIDED TO THE PATIENT. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS INSTEAD OF ORAL ANTIBIOTICS. THERE WAS NO REPORT OF HARM TO PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208729 REMISOL CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U. MSK KIT SERVER & CLIENT REMISOL V2.1 USB 15099590748036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other