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 Missing Test Results (3267)

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

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

A beckman national product specialist evaluated the remisol rules and noticed that the rule for holding sample with sample id 'xx' was not set.The beckman national product specialist entered the remisol rules to hold samples with sample id ¿xx¿ to resolve the issue.Customer performed testing and the rules played as expected.Pt info: information not provided by customer.Phone number is (b)(4).The beckman coulter internal identifier is (b)(4).

Event Description

The customer reported patient samples did not get received with demographics and showed up in remisol with patient id starting with ¿xx¿.The patient samples did not hold up in remisol for review.It was reported that one patient sample result was delayed and resulted in delay of surgery.There was no report of harm to this patient.No additional information was provided.There was no report of death associated with this event.The customer did not provide patient data or demographics.The customer only provided the identification number for this patient sample, sample id (b)(4).

• 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.; 7 rue frederic degeorge; arras cedex 62028 ; FR 62028
• Manufacturer (Section G): NORMAND-INFO S.A.S.U.; 7 rue frederic degeorge; bat b 2ieme etage; arras cedex 62028 ; FR 62028
• Manufacturer Contact: christine xardel ; 7 rue frederic degeorge; bat b 2 ieme etage; arras 62028 ; FR 62028
• MDR Report Key: 14197775
• MDR Text Key: 294645604
• Report Number: 3006543086-2022-00002
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2022

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: WORK STATION OPTIPLEX7050 HW RADV
• Device Catalogue Number: C24275
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/25/2022
• 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): Other