MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is related to the events reported with radiometer ref.(b)(4) (mdr# 3002807968-2025-00123) and (b)(4) (mdr# 3002807968-2025-00124).
Event or Problem Description
Radiometer complaint reference (b)(4).According to the complaint, the abl800 flex analyzer reported falsely high sodium (na) values and falsely low chloride (cl) values, leading to inaccurately low anion gap readings.The recorded anion gap values ranged from 0.2 to 2.9 mmol/l, whereas the expected range was 10 to 16 mmol/l.This issue occurred between (b)(6) and (b)(6) 2025.It was reported to have resulted in inappropriate treatment, but no adverse events were identified.
Additional Manufacturer Narrative
Based on measurement results revealed during investigation the risk assessment has been revised with the conclusion that the incident would not be likely to cause or contribute to death or serious injury.Therefore, this incident does not meet the criteria for a reportable mdr.
Additional Manufacturer Narrative
Radiometer has received additional method comparison data (abl800 vs.Abl90) as well as device data.A thorough review of all available data has been completed.The analysis shows that, in the period prior to replacing the reference membrane (lot r3740 on oct 21) and the reference electrode (lot 92 04 on oct 23), the abl800 results were within the performance specifications, although close to the allowable limits.Following these replacements, the differences, including standard deviations, showed considerable improvement.Review of the calibration data indicates frequent calibration drift errors with the electrolyte parameters, the pattern of which indicates that the increased calibration drift was caused by the reference sensor.One cna+ value from the period (b)(6) 2025 11:30 to (b)(6) 2025 06:08 slightly exceeded the performance requirement.However, the time between sample collection and analysis varied greatly, and the samples included discarded routine-analysis samples.These factors may have contributed additional uncertainty and could explain the cna+ value, although this cannot be confirmed.In conclusion, the issue was caused by the reference sensor, but the precise rc of the problem could not be determined.Radiometer is in dialogue with the customer and has presented the investigation results, which the customer has acknowledged.

• 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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 23288080
• Report Number: 3002807968-2025-00122
• Device Sequence Number: 8854681
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2704N015
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 01/21/2026

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: 09/19/2025
• Supplement Date Received by Manufacturer: 10/24/2025; 01/16/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/07/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2020
• 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