MAUDE Adverse Event Report: NORMAND-INFO S.A.S.U. REMISOL ADVANCE HARDWARE TOWER SERVER 2012; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number REMISOL ADVANCE HARDWARE TOWER SERVER 2012

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2024

Event Type  Injury  

Event Description

The customer reported the remisol ruleset incorrectly changed the result to <5 rather than triggered a rule to generate a comment to dilute the sample and rerun.It was confirmed that due to the incorrect (lower) result reported out of the laboratory and the patient was released from the hospital.The patient sought a second opinion at a different hospital and was admitted for treatment.No further details were provided.There was no report of harm to the patient.The customer did not provide patient data or demographics.

Manufacturer Narrative

Beckman coulter customer technical support (cts) remotely connected to the customer's remisol server and reviewed sample with the customer.Original result was "ir hr rl sd ol".The "ol" triggered the "less than 5¿ rule which converted the result to "<5" as it was intended.Customer stated that the "ir" in the result should have triggered the "greater than 4,100¿ rule.Examination of the rule showed that the "ir" flag was not a part of that rule.The "ir" flag that the customer wanted to cause a rule to fire, was not part of the ruleset.The failure mode was determined to be use error.Cts modified the <5 rule to autovalidate to dilute the sample and rerun to resolve the issue.Section a2, a4, and a5: information not provided by customer.The beckman coulter internal identifier is (b)(4).

• Brand Name: REMISOL ADVANCE HARDWARE TOWER SERVER 2012
• 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 5; FR 620285
• Manufacturer (Section G): NORMAND-INFO S.A.S.U.; 7 rue frederic degeorge; bat b 2 ieme etage; arras cede 62028 ; FR 62028
• Manufacturer Contact: christine xardel ; 7 rue frederic degeorge; bat b 2 ieme etage, arras cede; FR 62028 ; 3362791069
• MDR Report Key: 18681932
• MDR Text Key: 335073511
• Report Number: 3006543086-2024-00001
• 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: 02/09/2024

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: REMISOL ADVANCE HARDWARE TOWER SERVER 2012
• Device Catalogue Number: 08050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• 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