MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number	393-092
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint, the customer reported that on (b)(6) 2026 and (b)(6) 2026, the blood gas analyzer abl90 flex plus analyzer (serial number (b)(6)) gave erratic pco2 results, also when compared to another analyzer ((b)(6)) in the intensive care unit (icu).The patient was on a non-invasive ventilator for which they did not change the settings over the course of the readings they are concerned about.They would have expected the pco2 to come down over the two days they have readings for, but they had two erratic readings.
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint, the customer reported that from 24feb2026 to 26feb2026, the blood gas analyzer abl90 flex plus analyzer (serial number (b)(6)) gave erratic pco2 results, also when compared to another analyzer (b)(6) in the intensive care unit (icu).The patient was on a non-invasive ventilator for which they did not change the settings over the course of the readings they are concerned about.They would have expected the pco2 to come down over the two days they have readings for, but they had two erratic readings.
Additional Manufacturer Narrative
Following have been corrected: section b5: dates on when the event happened was corrected from "on 24feb2026 and 25feb2026" to "from 24feb2026 to 26feb2026".Section b6: last date of comparison measurement was corrected from 25feb2026 to 26feb2026.Section g3: in the initial report it was stated the date of awareness being 26feb2026.It should be corrected in 27feb2026.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Common Device Name: ABL90 FLEX PLUS ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: paola giglio ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 24579775
• Report Number: 3002807968-2026-00030
• Device Sequence Number: 15742708
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0546N008
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/20/2026

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
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 41 KG