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

Model Number	393-092
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer complaint reference: (b)(4).According to complaint, customer reported that there have been 5 different patient samples that have had very low total hemoglobin (thb) results ranging from 0.1 to 12 g/l between (b)(6) 2026 from blood gas analyzer abl90 flex plus analyzer (serial number (b)(6)).There were no error messages on the samples and samples from these patients performed in the lab have given normal results.The sample measurements are as follows: sample id: measurement time and date: parameter: result: (b)(6) 22:09 (b)(6) 2026 thb, 1.4 g/l discrepant, lab result 05:30 (b)(6) 2026 thb, 96 g/l comparison, lab result 22:16 (b)(6) 2026 thb, 96 g/l comparison, (b)(6) 22:11 (b)(6) 2026 thb, 70 g/l comparison; (b)(6) 14:44 (b)(6) 2026 thb, 0.3 g/l discrepant, lab result 07:40 (b)(6) 2026 thb, 86 g/l comparison, lab result 07:38 (b)(6) 2026 thb, 90 g/l comparison, (b)(6) 13:46 (b)(6) 2026 thb, 85 g/l comparison, (b)(6) 09:34 (b)(6) 2026 thb, 84 g/l comparison; (b)(6) 11:08 (b)(6) 2026 thb, 0.1 g/l discrepant, lab result 09:09 (b)(6) 2026 thb, 108 g/l comparison, lab result 14:31 (b)(6) 2026 thb, 102 g/l comparison, (b)(6) 17:55 (b)(6) 2026 thb, 107 g/l comparison, (b)(6) 15:14 (b)(6) 2026 thb, 103 g/l comparison; (b)(6) 16:28 (b)(6) 2026 thb, 1.8 g/l discrepant, lab result 08:58 (b)(6) 2026 thb, 104 g/l comparison, lab result 13:38 (b)(6) 2026 thb, 114 g/l comparison; (b)(6) 23:08 (b)(6) 2026 thb, 12 g/l discrepant, lab result 08:41 (b)(6) 2026 thb, 85 g/l comparison, lab result 22:51 (b)(6) 2026 thb, 92 g/l comparison, (b)(6) 15:04 (b)(6) 2026 thb, 89 g/l comparison, (b)(6) 03:41 (b)(6) 2026 thb, 90 g/l comparison.

• 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: 25158520
• Report Number: 3002807968-2026-00058
• Device Sequence Number: 9315721
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0625N035
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 07/02/2026

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: 05/01/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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