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	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event is estimated.
Event or Problem Description
According to the complaint the customer experienced a mpi (master patient index) issue with none radiometer device lumiradx on aqure (version 2.6.0.).The query on lumiradx with abnormal query success on the device with error message (on device) following query.Device software version: device:v1.21-hub:v4.2.14.
Additional Manufacturer Narrative
Radiometer investigation of received data logs has identified that the incident occurred due to a software error in the driver connected to the lumiradx device (non radiometer device) which was keeping the mpi query response messages in queue.This can cause this response message fail to deliver to the device.
Additional Manufacturer Narrative
There are currently no users in usa using the lumiradx connected to aqure, thus there is no risk for patient mix-up to occur in the usa.A recall (915-424) has been initiated in order to remove the affected lumiradx driver from all aqure installations in the usa in order to prevent the error to occur in the future if any aqure customers begin using aqure together with lumiradx.

• 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: anders noerregaard ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 15968383
• Report Number: 3002807968-2022-00041
• Device Sequence Number: 5549920
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2023

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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 02/27/2023; 11/30/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/09/2023; 03/03/2023; 03/23/2023
• 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