MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

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	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to complaint, deviating na+ results were detected by customer on patient results in relation to the patients' previous results.This deviation originates from two occasions with deviant na+ results on the abl800 flex analyzer (serial number: (b)(6)).On both occasions, calibrations and qc were approved.Patient results were checked against the central laboratory.Occasion 1: time (b)(6) 2024 17:56 patient samples were analyzed and a na+ result of 155.6 mmol/l was obtained.The user did not trust this because the patient four hours earlier had 143 mmol/l.A venous sample was then taken in a vaccutainer which was sent to the laboratory where a na+ result of 141 mmol/l was obtained.After this, a 2-point calibration was performed which was not approved for na, ca and cl.Occasion 2: time (b)(6) 2024 07:58 a new comparison was performed between the abl and the laboratory.On this occasion the abl indicated a na+ of 160 mmol/l while the laboratory reported a na+ of 147 mmol/l.At the time of analysis, the instrument was approved for calibrations and qc.On the 19th, electrodes for na+ and ref were changed as well as their membranes at the request of service technicians.However, the customer did not indicate on this occasion that they would write a deviation report.The next day (the 20th) we learned that they had written an internal discrepancy report.
Additional Manufacturer Narrative
Radiometers investigation of the provided data concludes that not enough information is present to determine the component or root cause.Reference and na electrodes were exchanged.Inspection of the reference and ph electrodes is recommended, as well as the cleaning of the chambers and the electronic contacts.
Additional Manufacturer Narrative
The results of the investigation performed indicate that the root causes stated below need to be present in combination: the reference electrode (945-603) is contaminated on the surface due to a problem with leakage of inner solution from the reference membrane unit (942-058).This can cause unintended electrical contact of the electrode to the instrument chassis.Increased leakage current (but within the limits of leakage current detection) in the wet section.Met ii module (902-842): replacing the module decreased the leak current, but isolation test in analyzer production did not indicate failure on the module.Crea membrane (942-073): replacing the membranes can alter the magnitude of the leak current.Conductivity of the sample is lower than the calibration solutions, i.E.Bias is only experienced on blood samples (the higher cthb the larger bias was determined).Qc samples seem to be less affected, so unacceptable bias can occur without qc error.

• Brand Name: ABL800 FLEX ANALYZER
• Common Device Name: ABL800 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: anette gram ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 20851954
• Report Number: 3002807968-2024-00082
• Device Sequence Number: 12772617
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R1709N006
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 02/13/2025

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: 11/20/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 01/14/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/20/2025; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2013
• 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