MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer complaint reference: (b)(4).According to complaint, the customer complains about abl800 flex analyzer (serial no.(b)(6) briefly showed the basic input/output system (bios) info and then gave black screen despite replacement of central processing unit (cpu) unit.No adverse event or serious injury were identified.
Additional Manufacturer Narrative
The investigation of returned cpu unit shows it malfunctioned.Hence the root cause is component failure.This complaint occured on (b)(6) 2021 and was re-opened on (b)(6) 2025 in an internal quality review and reassessed in relation to a capa (capa-01335).It is now deemed reportable.

• Brand Name: ABL800 FLEX
• Common Device Name: ABL800 FLEX
• 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: bernarda radoncic ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 23462308
• Report Number: 3002807968-2025-00129
• Device Sequence Number: 21440510
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R1926N007
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K041874
• 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
• Report Date (Section B): 11/04/2025

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: 393-800
• Device Catalogue Number: 393-800
• 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: 05/14/2021
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2014
• 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