MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS 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	01/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint the hospital reported, on (b)(6) 2025, after performing an arterial blood draw and proceeding with the blood analysis, the pco2 value was found to be higher than normal.The blood gas values were inaccurate, which could affect the diagnosis of the patient's condition.It is necessary to redraw the blood and use a different blood gas analyzer for testing.New information received 14feb2025: at 1:10 am on (b)(6) 2025, using (b)(6), the patient sample test result showed pco2 106 mmhg.The customer believes this result does not match the patient's clinical presentation.At 1:17 am on (b)(6) 2025, using (b)(6), another analyzer at the hospital tested the same sample and obtained a result of 33.9 mmhg.The engineer reported that before the customer tested the sample, (b)(6) had already failed pco2 calibration and qc with error codes 0377 and 0589.As a result, the solution pack (sp) was replaced for the customer.
Event or Problem Description
According to the complaint the hospital reported, on (b)(6) 2025, after performing an arterial blood draw and proceeding with the blood analysis, the pco2 value was found to be higher than normal.The blood gas values were inaccurate, which could affect the diagnosis of the patient's condition.It is necessary to redraw the blood and use a different blood gas analyzer for testing.New information received 14feb2025: at 1:10 am on (b)(6), using (b)(6), the patient sample test result showed pco2 106 mmhg.The customer believes this result does not match the patient's clinical presentation.At 1:17 am on (b)(6) using (b)(6), another analyzer at the hospital tested the same sample and obtained a.Result of 33.9 mmhg.The engineer reported that before the customer tested the sample, (b)(6) had already failed pco2 calibration and qc with error codes 0377 and 0589.As a result, the solution pack (sp) was replaced for the customer.New information received 26feb2025: service dump recieved.
Additional Manufacturer Narrative
The radiometer investigation has concluded that the cause for the pco2 measurement is measure higher than normal for the period where the incident happen is due to a damaged pco2 sensor.The damaged pco2 sensor is detected by calibration and the automatic quality control performed at the abl90 and is flagged with a ?.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Common Device Name: ABL90 FLEX PLUS 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: ditte krøyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 21408650
• Report Number: 3002807968-2025-00012
• Device Sequence Number: 15532920
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0571N011
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/14/2025

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: 01/26/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2014
• 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