MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	Low Readings (2460)
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 number: (b)(4) according to the complaint unplausible ph values were measured on (b)(6) 2025 at 13:27 and 13:59; the abl800 flex plus analyzer (serial no; (b)(6) was displaying a green status at this time.Comparative measurements were performed on 3 abl800 devices using 2 patients from different safe pico a syringes (lot dx17), with the ph value on the faulty device being approx.0.2 too low.Operating materials used: cal 1 lot cz03, cal 2 lot cz02, rinsing solution lot dz65, cleaning solution cy02, gas 1 y29b68, gas 2 y17g82, ref.Membrane lot r3594.Sample/patient id (b)(6), 13:37, (b)(6) 2025, ph 7,036 (discrepant), sample/patient id (b)(6), 13:44, (b)(6) 2025, ph 7,202 (comparison), sample/patient id (b)(6), 13:52,(b)(6) 2025, ph 7,207 (comparison).No one was injured.The abl800 flex plus analyzer is running fine after electrode replacement.
Additional Manufacturer Narrative
The radiometer investigation has not been able to identify the specific root cause, hence root cause remains unknown.The electrode was replaced.The analyzer was running fine after electrode replacement.Customer has not taken any action.

• 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: 22685435
• Report Number: 3002807968-2025-00103
• Device Sequence Number: 21030102
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2880N026
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/09/2025

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: 393-800
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 100 KG