MAUDE Adverse Event Report: RADIOMETER MEDICAL APS AQURE

Model Number	933-599
Medical Device Problem Codes	Computer Software Problem (1112); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer complaint reference: (b)(4).According to the complaint, the result values did not match after unit conversion factor was applied between the analyzer patient data logs and aqure (serial number: (b)(6)).Out of 583 results, 21 of them did not match.This was not used during treatment of patients.
Additional Manufacturer Narrative
Date of event is estimated based on date received by manufacturer.
Additional Manufacturer Narrative
It was confirmed by the customer that the analyzer nor the software had failed.Hence the root cause is no malfunction, and the analyzer had worked as intended.Therefore, this incident does not meet the criteria for a reportable mdr.

• Brand Name: AQURE
• Common Device Name: AQURE
• 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: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 23050156
• Report Number: 3002807968-2025-00116
• Device Sequence Number: 9665572
• Product Code: OUG
• UDI-Device Identifier: 05700699335999
• UDI-Public: (01)05700699335999
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPTED
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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