BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE - SERVER

    MDR report key: 15677561 · Received October 26, 2022

    Report

    Report Number
    3006543086-2022-00003
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    September 26, 2022
    Report Date
    November 23, 2022
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECKMAN COULTER FIELD SERVICE ENGINEER WAS SENT TO THE CUSTOMER SITE TO EVALUATE THE REMISOL. THE REMISOL VIEWER FILES ARE IN THE PROCESS OF BEING REVIEWED BY BECKMAN COULTER REMISOL TEAM. A MALFUNCTION IS BEING ASSUMED AS WORST CASE SCENARIO AND INVESTIGATION INFORMATION WILL BE UPDATED ACCORDINGLY. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER TO CONFIRM THE TWO (2) PATIENTS WERE AFFECTED. INFORMATION NOT PROVIDED BY CUSTOMER. UDI CODE NOT AVAILABLE. (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE VIEWERS AND SCREENSHOTS FROM REMISOL WINDOWS WERE ANALYZED BY NORMAND TECH SUPPORT TEAM AND REVEALED THAT THERE WAS NO OBSERVED DELAY CAUSED BY REMISOL. BECKMAN TECHNICAL SUPPORT TEAM CONFIRMED THAT THE CUSTOMERS MODULES IN THE SUNQUEST LABORATORY INFORMATION SYSTEM WAS DOWN, LEADING TO THE DELAY OF SAMPLE PROCESSING. THE SUNQUEST LABORATORY INFORMATION SYSTEM IS NOT MANUFACTURED OR DISTRIBUTED BY BECKMAN COULTER. THERE WAS NO EVIDENCE OF MALFUNCTION OF A BECKMAN COULTER DEVICE, AND NO EVIDENCE OF AN INJURY OR CHANGE IN PATIENT TREATMENT DUE TO THE OUTPUT OF THE DEVICE IN THIS EVENT. UPON FURTHER INVESTIGATION, IT WAS CONFIRMED THIS IS NO LONGER A REPORTABLE EVENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TWO (2) PATIENTS WITH HIGH TROPONIN RESULTS HAD POTENTIALLY BEEN HARMED DUE TO THE TIME IT TOOK TO GET RESULTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER TO CONFIRM THE PATIENTS WERE AFFECTED. INVESTIGATION IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THERE WAS DELAY IN PATIENT SAMPLE PROCESSING DUE TO AN ALLEGED REMISOL CRASH. REMISOL SERVICES STOPPED AFTER REBOOTING DUE TO PORT SCAN, CUSTOMER STATED THAT THE BACKLOG WAS AFFECTING THEIR TURN-AROUND-TIME FOR TROPONIN AND THAT TWO (2) PATIENTS WITH HIGH TROPONIN RESULTS HAD POTENTIALLY BEEN HARMED DUE TO THE DELAYED TIME IT TOOK TO GET RESULTS. UPON ADDITIONAL INVESTIGATION, THERE WAS NO FURTHER HARM CONFIRMED TO THE PATIENTS. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT. IT WAS INDICATED THAT THE REMISOL SERVICES HAD STOPPED AFTER REBOOTING DUE TO A PORT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546494 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other