MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number	393-090
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth is estimated.
Event or Problem Description
According to the complaint, an arterial sample of patient on the abl90 flex analyzer (serial no.(b)(6)) gave credible values for all parameters except a lactate of 6.4 mmol/l.A second venous sample was taken from the same patient one hour later and measured on another analyzer which gave a more credible result for lactate of 2.3 mmol/l.After 2 hours a third sample was measured on both analyzers with very similar results are for lactate (5.6 and 5.7 mmol/l).
Additional Manufacturer Narrative
The data logs did not indicate any malfunction, hence, the root cause could not be identified.The most likely reason to the discrepancy for sample 2 can be a kind of interference in the sample - it may be connected to the fact, that patient is treated with k and insulin.Having asked for info on sampling, the answer was, that all samples were done via needle/syringe, so that can not confirm the hypothese at that stage of sampling.

• Brand Name: ABL90 FLEX ANALYZER
• Common Device Name: ABL90 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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 21512501
• Report Number: 3002807968-2025-00017
• Device Sequence Number: 20826737
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0880N008
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K120197
• 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): 03/31/2025

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: 393-090
• Device Catalogue Number: 393-090
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2017
• 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: 19 YR
• Patient Sex: Female
• Patient Weight: 60 KG