MAUDE Adverse Event Report: NORMAND-INFO SASU RADV SERVER LICENSE VIRTUAL; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number RADV SERVER LICENSE (1 HOST 3 INSTRUMENTS) VIRTUAL

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  Injury  

Event Description

The customer reported the low methotrexate patient result of 0.05 was auto validated in remisol system and reported the result as <0.08 out of the laboratory.The customer indicated patient management was changed.The patient was treated due to low result.No additional information was provided regarding treatment.The customer later repeated the sample straight and dilution, both results were higher.There was no report of death associated with this event.The customer did not provide patient demographics.The customer provided initial result for this patient.

Manufacturer Narrative

Beckman customer technical support specialist (cts) performed troubleshooting and reviewed remisol rules setting.The rules showed the analytical measurement range (amr) low was set as <0.08.The result of 0.05 was converted to <0.08 and released correctly.The remisol rules played as expected.Based on the available information, there was no evidence of a remisol malfunction.The failure mode was unknown.Section e1, reporter telephone number is (b)(6).Beckman coulter internal identifier is (b)(4).

• Brand Name: RADV SERVER LICENSE VIRTUAL
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): NORMAND-INFO SASU; 7 rue frederic degeorge; arras cedex 91420 ; FR 91420
• Manufacturer (Section G): NORMAND-INFO S.A.S.U.; 7 rue frederic degeorge; bat b 2 ieme etage; arras cedex 62028 ; FR 62028
• Manufacturer Contact: christine xardel ; 7 rue frederic degeorge; bat b 2 ieme etage; arras cedex 62028 ; FR 62028
• MDR Report Key: 18744415
• MDR Text Key: 335813849
• Report Number: 3006543086-2024-00002
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: RADV SERVER LICENSE (1 HOST 3 INSTRUMENTS) VIRTUAL
• Device Catalogue Number: C57013
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• 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