BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL ADVANCE VIRTUALIZED SERVER 2012

    MDR report key: 9169992 · Received October 8, 2019

    Report

    Report Number
    3006543086-2019-00001
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    September 10, 2019
    Report Date
    October 8, 2019
    Manufacturer
    NORMAND-INFO S.A.S.U
    Product Code
    JQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AND COULD NOT IDENTIFIED THE CAUSE OF THE FAILURE. CORRECT RESULT FOR PATIENT ID (B)(6) INTEGRATED IN REMISOL INCLUDING B_WBC, BUT NOT AUTO VALIDATED. THE CUSTOMER PERFORM MANUAL VALIDATION OF THE CORRECT B_WBC RESULT TO RESOLVE THE ISSUE. INFORMATION NOT PROVIDED BY THE CUSTOMER. DEVICE MANUFACTURE DATE: UNKNOWN. THE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE - (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS RESULTS AUTO VALIDATED BY REMISOL. ERRONEOUS RESULTS FOR 20 OF 21 PARAMETERS WERE REPORTED OUTSIDE THE LABORATORY. THESE RESULTS WERE MISMATCHED FROM ANOTHER PATIENT. PATIENT ID (B)(6) RESULTS WERE ASSIGNED TO PATIENT ID (B)(6). A PATIENT ID (B)(6) RECEIVED CHEMOTHERAPY BASED ON ERRONEOUS RESULTS. PATIENT ID (B)(6) WAS NOT IMPACTED. THE CUSTOMER DID NOT PROVIDE ANY DATA OR FURTHER INFORMATION ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961213 REMISOL ADVANCE VIRTUALIZED SERVER 2012 CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U REMISOL ADVANCE VIRTUALIZED SERVER 2012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other