MAUDE Adverse Event Report: NORMAND-INFO S.A.S.U. REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE - SERVER; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE - SERVER

Device Problems High Test Results (2457); Device Handling Problem (3265)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2022

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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).

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE - SERVER
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): NORMAND-INFO S.A.S.U.; 7 rue frederic degeorge; bat b 2ieme etage; arras cedex 62028 ; FR 62028
• Manufacturer (Section G): NORMAND-INFO S.A.S.U.; 7 rue frederic degeorge; bat b 2ieme etage; arras cedex 62028 ; FR 62028
• Manufacturer Contact: christine xardel ; 7 rue frederic degeorge; bat b 2 ieme etage; FR 62028
• MDR Report Key: 15677561
• MDR Text Key: 302471491
• Report Number: 3006543086-2022-00003
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE - SERVER
• Device Catalogue Number: C57017
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other