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	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint the hospital reported, while performing a blood gas test for a patient, after completing the test and printing the report, it was discovered that the internal clock of the abl90 flex analyzer (serial no; (b)(6) was incorrect.The correct time was 17:37 on (b)(6) 2025, but the actual displayed time was 11:57 on (b)(6) 2023.The incorrect time display caused the report time to not match the actual test time.
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint the hospital reported, while performing a blood gas test for a patient, after completing the test and printing the report, it was discovered that the internal clock of the abl90 flex analyzer (serial no: (b)(6)) was incorrect.The correct time was 17:37 on (b)(6) 2025, but the actual displayed time was 11:57 on (b)(6) 2023.The incorrect time display caused the report time to not match the actual test time.New information received on 12jun2025: the engineer reported that there was a sudden power outage at the customer's site.After the analyzer was restarted, there was an issue with time disorder.It returned to normal after being reset.The servicedump is unavailable.
Additional Manufacturer Narrative
The radiometer investigation has found that the failure is not related to production process; however, the specific root cause remains unknown, due to insufficient information provided.It is communicated to the customer that this situation could occur and that customer is responsible to set the right date time when asked.Date time is already corrected.

• 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: ditte krøyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22192989
• Report Number: 3002807968-2025-00078
• Device Sequence Number: 9310916
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1196N002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 06/26/2025

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: 06/09/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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