MAUDE Adverse Event Report: RADIOMETER MEDICAL APS AQURE SYSTEM

Model Number	933-599
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event in b3 is estimated.
Event or Problem Description
According to the complaint, the customer entered the wrong patient data through manual entry on the abl90 flex plus analyzer (serial number: (b)(6).The customer then approved the sample results for the wrong patient.The results crossed over to aqure and then to ehr/his to the wrong patient.The customer then corrected the patient demographics on the sample on the machine, linking the results to the correct patient, but this was only changed in aqure and not over to their ehr/his system.
Additional Manufacturer Narrative
Information in section d4 were updated to the aqure system.Radiometer investigations of the abl90 flex plus analyzer (serial number: (b)(6) ) has shown that the analyzer did not fail.The abl90 flex plus analyzer did transmit the updated results to aqure, but from aqure the updated results did not reach the customer's his/lis.Radiometer investigation of the aqure system is still ongoing.Codes in h6 were updated to reflect the ongoing investigations of the aqure system and the completed investigations of the abl90 flex plus analyzer.
Additional Manufacturer Narrative
Investigation is finalized, with the conclusion that the product did not malfunction.Hence, this incident does not meet the criteria of a reportable mdr now.

• 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: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 18225889
• Report Number: 3002807968-2023-00060
• Device Sequence Number: 5366037
• Product Code: OUG
• UDI-Device Identifier: 05700699335999
• UDI-Public: 5700699335999
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2024
• 2 Devices were Involved in the Event: 1 2

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: 11/10/2023
• Supplement Date Received by Manufacturer: 11/29/2023; 02/19/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/20/2023; 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2019
• 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