MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer complaint reference: (b)(4).According to the complaint, the customer reported that on (b)(6) 2026, at 19:20, a blood gas analysis on the blood gas analyzer abl800 flex analyzer (serial number (b)(6)) was completed for the pediatric patient.The reported results showed potassium (k) of 2.5 mmol/l and sodium (na) of 117 mmol/l.The patient was immediately assessed and showed no signs of cardiac arrhythmia, seizures, or other abnormal manifestations.Compared with the blood gas results at 06:35 the same morning (k 3.4 mmol/l, na 132 mmol/l), the values differed significantly.An urgent repeat biochemical electrolyte test was ordered immediately.In the meantime, low-dose hypertonic sodium and potassium citrate supplementation were initiated.At 20:39, the biochemical electrolyte results were reported as k 3.9 mmol/l and na 134 mmol/l, and hypertonic sodium and potassium citrate supplementation were immediately discontinued.
Additional Manufacturer Narrative
Radiometer have requested data logs and service dumps, but were not provided.Hence the root cause remains unknown.

• 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: bernarda radoncic ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 24907803
• Report Number: 3002807968-2026-00049
• Device Sequence Number: 9799899
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2128N006
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/13/2026

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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2015
• 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