MAUDE Adverse Event Report: RADIOMETER MEDICAL APS AQURE SYSTEM

Model Number	933-599
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, the customer is facing an issue on aqure (version 2.6.1) when receiving parameter crp from lumiradx(third-party-device).When lumiradx sends <5,0 to aqure, the aqure system shows 50 mg/l.Another example shows a measurement of 33,4 mg/l where aqure shows 334 mg/l.
Additional Manufacturer Narrative
Aqure was working according to specification.The connected device (lumiradx) was not configured according to instructions which states that the third-party-device(lumiradx) must be configured to use dot(.) as decimal symbol.The connected device was configured to use comma(,) as decimal symbol.
Additional Manufacturer Narrative
Radiometer medical aps has received confirmation that the issue was discovered by a lumiradx representative and the customer in a test setup, not in a clinical situation.The risk has been re-assessed in and the complaint is no longer considered reportable.

• Brand Name: AQURE SYSTEM
• Common Device Name: AQURE SYSTEM
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 16929025
• Report Number: 3002807968-2023-00020
• Device Sequence Number: 7008249
• Product Code: OUG
• UDI-Device Identifier: 05700699335999
• UDI-Public: 05700699335999
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 933-599
• Device Catalogue Number: 933-599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 06/27/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/15/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown