MAUDE Adverse Event Report: Radiometer Medical ApS ABL800 FLEX with crea

Model Number	393-801
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction

• Brand Name: ABL800 FLEX with crea
• Common Device Name: ABL800 FLEX with crea
• 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: 50558285
• Report Number: 3002807968-2026-00089
• Device Sequence Number: 21459631
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R1780N008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/02/2026

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: 393-801
• Device Catalogue Number: 393-801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2014
• 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 Age: 60 YR
• Patient Sex: Male