BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL ADVANCE HARDWARE TOWER SERVER 2012

    MDR report key: 18681932 · Received February 9, 2024

    Report

    Report Number
    3006543086-2024-00001
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 30, 2024
    Report Date
    February 9, 2024
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) REMOTELY CONNECTED TO THE CUSTOMER'S REMISOL SERVER AND REVIEWED SAMPLE WITH THE CUSTOMER. ORIGINAL RESULT WAS "IR HR RL SD OL". THE "OL" TRIGGERED THE "LESS THAN 5¿ RULE WHICH CONVERTED THE RESULT TO "<5" AS IT WAS INTENDED. CUSTOMER STATED THAT THE "IR" IN THE RESULT SHOULD HAVE TRIGGERED THE "GREATER THAN 4,100¿ RULE. EXAMINATION OF THE RULE SHOWED THAT THE "IR" FLAG WAS NOT A PART OF THAT RULE. THE "IR" FLAG THAT THE CUSTOMER WANTED TO CAUSE A RULE TO FIRE, WAS NOT PART OF THE RULESET. THE FAILURE MODE WAS DETERMINED TO BE USE ERROR. CTS MODIFIED THE <5 RULE TO AUTOVALIDATE TO DILUTE THE SAMPLE AND RERUN TO RESOLVE THE ISSUE. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE REMISOL RULESET INCORRECTLY CHANGED THE RESULT TO <5 RATHER THAN TRIGGERED A RULE TO GENERATE A COMMENT TO DILUTE THE SAMPLE AND RERUN. IT WAS CONFIRMED THAT DUE TO THE INCORRECT (LOWER) RESULT REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS RELEASED FROM THE HOSPITAL. THE PATIENT SOUGHT A SECOND OPINION AT A DIFFERENT HOSPITAL AND WAS ADMITTED FOR TREATMENT. NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO REPORT OF HARM TO THE PATIENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109652 REMISOL ADVANCE HARDWARE TOWER SERVER 2012 CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U. REMISOL ADVANCE HARDWARE TOWER SERVER 2012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other