MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number	393-090
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation shows wet section control pcb causes error and analyzer needs to be restarted.Hence, the root cause is component failure.This complaint was re-opened on (b)(6) 2025 in an internal quality review and reassessed in relation to a capa.It is now deemed reportable.
Event or Problem Description
Radiometer reference number: (b)(4).According to complaint, customer reported that since (b)(6) 2023 the customer experience intermittently when running a sample, the abl90 flex analyzer (serial number (b)(6)) software freezes completely before the sample process is completed.Analyzer has to be rebooted to restore operation.

• Brand Name: ABL90 FLEX ANALYZER
• Common Device Name: ABL90 FLEX ANALYZER
• 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: anette gram ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22975936
• Report Number: 3002807968-2025-00114
• Device Sequence Number: 21146363
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: 05700693930909
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K092686
• 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): 09/05/2025

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: 393-090
• Device Catalogue Number: 393-090
• 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: 06/22/2023
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2012
• 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