BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE - SERVER

    MDR report key: 13778395 · Received March 16, 2022

    Report

    Report Number
    3006543086-2022-00001
    Event Type
    Injury
    Date Received
    March 16, 2022
    Date of Event
    February 16, 2022
    Report Date
    March 17, 2022
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    UDI-DI
    13700962600655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO BECKMAN COULTER FIELD SERVICE ENGINEER WAS REQUESTED AS THERE WAS NO EVIDENCE SUGGESTING AN ANALYZER MALFUNCTION. THE FAILURE MODE IS DETERMINED TO BE USE ERROR. THE CUSTOMER INDICATED THAT THE LABORATORY TEAMMATES AT ANOTHER LABORATORY FACILITY DID NOT HAVE THE APPROPRIATE SITES FILTERED ON THEIR REMISOL PENDING TABS AND DELETED SAMPLE RESULTS. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. SECTION G1, PHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Additional Manufacturer Narrative · 0

    NO BECKMAN COULTER FIELD SERVICE ENGINEER WAS REQUESTED AS THERE WAS NO EVIDENCE SUGGESTING AN ANALYZER MALFUNCTION. THE CUSTOMER IS PROACTIVELY WORKING WITH OTHER SITES AS NEEDED TO UPDATE THE TAB FILTERS. THE CUSTOMER HAS NOT CALLED BACK FOR ANY FURTHER ISSUE REGARDING THIS SPECIFIC EVENT. IT IS UNKNOWN AS WHAT HAS CAUSED THE ISSUE BASED ON THE AVAILABLE INFORMATION PROVIDED. AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: INFORMATION NOT PROVIDED BY CUSTOMER. MFR SITE PHONE NUMBER IS (B)(4). THE BECKMAN COULTER INTERNAL IDENTIFIER IS( B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE HEMATOLOGY PATIENT SAMPLES WERE RUN FROM CUSTOMER SITE AND PATIENT RESULTS REPORTED TO ANOTHER SITE. THE PATIENT RESULTS WERE DELETED OR VALIDATED. AS A RESULT, PATIENT TREATMENT WAS DELAYED AND RESULTED IN PROLONGED PATIENT CARE. THE DETAILS OF THIS CARE WAS NOT PROVIDED. CUSTOMER REPEATED THE PATIENT SAMPLES AND REPORTED CORRECT RESULTS OUT OF THE LABORATORY. THERE WAS NO REPORT OF INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE DEMOGRAPHICS OR PATIENT DATA. ONLY PROVIDED THE IDENTIFICATION NUMBERS FOR THREE (3) PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261163 REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE - SERVER CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U. REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE - SERVER N/A 13700962600655

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other