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

Model Number REMISOL ADVANCE VIRTUALIZED SERVER 2012

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

Patient Problem Cancer (3262)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

Beckman coulter field service engineer evaluated the system and could not identified the cause of the failure.Correct result for patient id (b)(6) integrated in remisol including b_wbc, but not auto validated.The customer perform manual validation of the correct b_wbc result to resolve the issue.Information not provided by the customer.Device manufacture date: unknown.The beckman coulter internal identifier is case - (b)(4).

Event Description

The customer reported erroneous results auto validated by remisol.Erroneous results for 20 of 21 parameters were reported outside the laboratory.These results were mismatched from another patient.Patient id (b)(6) results were assigned to patient id (b)(6).A patient id (b)(6) received chemotherapy based on erroneous results.Patient id (b)(6) was not impacted.The customer did not provide any data or further information on the patient.

• Brand Name: REMISOL ADVANCE VIRTUALIZED 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 2 ieme etage; arras pas-de-calais 62028 ; FR 62028
• Manufacturer (Section G): NORMAND-INFO S.A.S.U; 7 rue frederic degeorge; bat b 2 ieme etage; arras, arras pas-de-calais 62028 ; FR 62028
• Manufacturer Contact: christine xardel ; 7 rue frederic degeorge; bat b 2 ieme etage; arras
• MDR Report Key: 9169992
• MDR Text Key: 161975045
• Report Number: 3006543086-2019-00001
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2019

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 VIRTUALIZED SERVER 2012
• Device Catalogue Number: C05231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other