MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number	393-092
Medical Device Problem Codes	High Readings (2459); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4) according to the complaint, the customer reported that on (b)(6) 2026, the radiometer blood gas analyzer abl90 flex plus analyzer (serial number (b)(6) gave sodium (na) extreme high and partial pressure of carbon dioxide (pco2) extreme low results at samples with high hematocrit (hct).Discrepant values provided are compared vs.Comparison measurements.
Additional Manufacturer Narrative
In the follow-up 1 report radiometer clarifies that this case has not been assessed for total hemoglobin concentration (cthb) because the three cthb measurements (from which hematocrit is calculated) provided by the customer are consistent with each other indicating that this complaint does not involve inconsistent cthb/hematocrit results.
Event or Problem Description
Radiometer reference number: (b)(4).According to the complaint, the customer reported that on (b)(6) 2026, the radiometer blood gas analyzer abl90 flex plus analyzer (b)(6) gave sodium (na) extreme high and partial pressure of carbon dioxide (pco2) extreme low results at samples with high hematocrit (hct).Discrepant values provided are compared vs.Comparison measurements.

• 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: paola giglio ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 25111408
• Report Number: 3002807968-2026-00054
• Device Sequence Number: 10272451
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0659N035
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K160153
• 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): 06/04/2026

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: 393-092
• Device Catalogue Number: 393-092
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 05/22/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/22/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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 Sex: Unknown