MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number	393-090
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference: (b)(4).According to the complaint the customer reported, on (b)(6) 2025, a bedside blood gas test was conducted for a patient on an abl90 flex analyzer (serial no; (b)(6)), reporting a potassium (k) level of 7.2 mmol/l, which was abnormal.Venous blood was immediately collected from the patient and sent to the hospital laboratory for re-examination, which showed a k level of 4.0 mmol/l, within the normal range.There was a significant discrepancy between the bedside blood gas test and the venous test results.
Additional Manufacturer Narrative
The radiometer investigation has not been able to determine the root cause due to lack of data, parts and details.Hence, root cause remains unknown.
Event or Problem Description
Radiometer reference: (b)(4).According to the complaint the customer reported, on (b)(6) 2025, a bedside blood gas test was conducted for a patient on an abl90 flex analyzer (serial no; (b)(6), reporting a potassium (k) level of 7.2 mmol/l, which was abnormal.Venous blood was immediately collected from the patient and sent to the hospital laboratory for re-examination, which showed a k level of 4.0 mmol/l, within the normal range.There was a significant discrepancy between the bedside blood gas test and the venous test results.Information received 19aug2025: according to the complaint, the engineer inspected the analyzer and found no issues.External quality controls were performed, and comparative verification was conducted with the laboratory's other equipment, with no abnormalities detected in the abl90.Therefore, the engineer speculated that the issue might have been caused by pre-analytical errors such as hemolysis.Training has been arranged for the customer.The customer did not provide a servicedump.During the inquiry, it was discovered that the customer had reported an incorrect analyzer serial number in the ae report.The actual analyzer involved in the incident was (b)(6).

• 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: 22685783
• Report Number: 3002807968-2025-00104
• Device Sequence Number: 8892386
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R1152N003
• 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): 08/29/2025

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: 07/30/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2021
• 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