MAUDE Adverse Event Report: NORMAND-INFO S.A.S.U. WORK STATION, OPTIPLEX7050, HW, RADV; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number WORK STATION, OPTIPLEX7050, HW, RADV

Device Problem Use of Device Problem (1670)

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

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

Beckman coulter customer technical support (cts) remotely connected to remisol and checked the example that was provided by the customer.Cts showed the customer that there were critical results and based on the rules, remisol will not upload critical results unless the technician uploads them manually.Cts showed the customer that the technician uploaded the results about an hour after the results came to remisol.The issue was due to a use error.Customer agreed with the findings and stated that they will communicate with the technician as to why it took an hour to upload the results.Delayed result caused delayed patient discharge from the hospital.There was no impact to the patient diagnostics or treatment.Age or dob, weight, ethnicity: information not provided by customer.Phone number is (b)(6).The beckman coulter internal identifier is (b)(4).

Event Description

The customer reported that the patient questioned hospital about result received to the remisol which was delayed to reach lis (laboratory information system).There is no report of erroneous result generated or reported out of the lab.The result was one hour delayed reaching to lis.Delayed result caused delayed patient discharge from the hospital.There was no impact to the patient diagnostics or treatment.

• Brand Name: WORK STATION, OPTIPLEX7050, HW, RADV
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): NORMAND-INFO S.A.S.U.; 1 rue du dr albert schweitzer; 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 2 ieme etage; arras 62000 ; FR 62000
• MDR Report Key: 12457414
• MDR Text Key: 272878671
• Report Number: 3006543086-2021-00003
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 15099590704223
• UDI-Public: (01)15099590704223(11)NO-DATA
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WORK STATION, OPTIPLEX7050, HW, RADV
• Device Catalogue Number: B15422
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization