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

Model Number	393-092
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint, a rented blood gas analyzer abl90 flex plus analyzer (serial number (b)(6)) was used by the customer as a temporary alternative, as their usual abl90 flex plus analyzer (serial number (b)(6)) needed repair.The field service engineer (fse) set up the abl90 flex plus analyzer (serial number (b)(6)) under the hospital's usage conditions and conducted an online test in demo mode.However, the fse forgot to turn off the demo mode.After that, the customer measured patient samples on the abl90 flex plus analyzer (serial number (b)(6)) without noticing in demo mode, but they quickly realized it.As a result, no health problems were reported in this case.This is clearly human error report, and radiometer japan (rkk) will once again issue a warning to all employees.
Additional Manufacturer Narrative
Case of incident is estimated and the date of awareness has been used in this report.

• 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: 24649267
• Report Number: 3002807968-2026-00035
• Device Sequence Number: 13208190
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0337N003
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/20/2026

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
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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