MAUDE Adverse Event Report: RADIOMETER MEDICAL APS AQURE

Model Number	933-599
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer complaint reference: (b)(4).According to the complaint, the customer is having issues reprocessing results, as an error happens after adt look up with aqure.The look up has been successful as the look up box is below the error box.This happens when the user pressed "ok".[after clicking on initial 'ok', it returns, 'save error': 'the server did not save the sample.Check your network connection or try again later.'] the result then stays as pending but cannot be reprocessed [after reprocessing, patient demographics was updated but result is in "approval status: pending", but the patient demographics are populated].No reports of death or serious injury.
Additional Manufacturer Narrative
Date of incident is estimated based on awareness date.
Additional Manufacturer Narrative
Radiometer investigations have concluded the root cause to be software design error.

• 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: 22768940
• Report Number: 3002807968-2025-00106
• Device Sequence Number: 15733413
• Product Code: OUG
• UDI-Device Identifier: 05700699335999
• UDI-Public: (01)05700699335999
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 10/14/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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