MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 LEX PLUS

Model Number	393-092
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer complaint reference (b)(4).According to the complaint, the abl90 flex plus analyzer (serial number (b)(6)) located in the nicu ward has reported repeated 1190 inlet open errors.When this error occurs, the sample is aborted, and the analyzer enters an "intervention required" state with the instruction to replace the inlet gasket holder.The customer followed the recommended troubleshooting steps without replacing any components, after which the analyzer resumed normal operation.No deaths or serious injuries have been reported in connection with this complaint.

• Brand Name: ABL90 LEX PLUS
• Common Device Name: ABL90 LEX PLUS
• 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: 24494817
• Report Number: 3002807968-2026-00020
• Device Sequence Number: 12038321
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0656N039
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K160153
• 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): 04/23/2026

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: 393-092
• Device Catalogue Number: 393-092
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• 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