MAUDE Adverse Event Report: NORMAND-INFO S.A.S.U. REMISOL ADVANCE

Catalog Number B45773

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

Normand technical support and an informatics technical specialist reviewed the issue, and observed the auto-validation stopping comment linked to ferritin was removed when the result was deleted.Then when the sample was rerun, this comment was not recreated because the rule that generated it was configured to play once.This led to the ferritin result being auto-validated as the auto-validation rule was unable to find the missing comment.The cause of the issue is attributed to use error due to an incorrect rule and the customer deleting a result.The issue was resolved by modifying the rule in remisol and discussing the correct management of the failure and results with the customer.(b)(4).

Event Description

The customer reported their remisol auto-validated an erroneous patient result for ferritin.The erroneous result was auto-released out of the laboratory.The physician stopped treatment for a patient based on the erroneous result.Patient treatment was resumed upon notification of the issue.No specific details of the patient treatment were provided.There was no report of harm to the patient.No details were provided in regards to the instrument used to run the patient sample.

• Brand Name: REMISOL ADVANCE
• Type of Device: REMISOL ADVANCE
• Manufacturer (Section D): NORMAND-INFO S.A.S.U.; 7 rue frederic degeorge; bat b 2ieme etage; arras pas-de-calais, 62028 ; FR 62028
• Manufacturer (Section G): NORMAND-INFO S.A.S.U.; 7 rue frederic degeorge; bat b 2ieme etage; arras pas-de-calais, 62028 ; FR 62028
• Manufacturer Contact: christine xardel ; 7 rue frederic degeorge; bat b 2ieme etage; arras pas-de-calais, 62000 ; FR 62000
• MDR Report Key: 7949512
• MDR Text Key: 123195352
• Report Number: 3006543086-2018-01000
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 13700962600938
• UDI-Public: (01)13700962600938(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2018

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 Catalogue Number: B45773
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR