MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint the customer experienced that their abl800 flex analyzer (serial number; (b)(6)) measured approximately 20 mmol too high for sodium (na) for about an hour from 11:51 to 12:53 on (b)(6) 2026.A sample was run on the analyzer at 11:48, but it did not produce a result, and other samples from the same time on different analysis equipment also failed, as they were coagulated.At 12:53, the analyzer resolved the problem on its own and measured correctly again.The patient has na results of 132 mmol/l on the 16/2-26 at 10:31 from alinity instrument.On the abl800 flex analyzer they received na results on 157 mmol/l 16/2-26 at 12:00 and 153 mmol/l 16/2-26 at 12:27 they have checked if there was saline water running but that was apparently not the case.

• Brand Name: ABL800 FLEX
• Common Device Name: ABL800 FLEX
• 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: 24387691
• Report Number: 3002807968-2026-00016
• Device Sequence Number: 21378731
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R1929N001
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K041874
• 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): 04/08/2026

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: 393-800
• Device Catalogue Number: 393-800
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2014
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown