MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Codes	Computer Software Problem (1112); Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4).According to complaint, our radiometer sales representative (rkk) reported from the customer about this on (b)(6) 2025 when he visited at the customer site but the problem seemed happened on (b)(6) 2025.The capillary measurement data loss from the abl800 flex analyzer (serial number (b)(6)).The customer reported the analyzer behavior was as below.1.Read the barcode for the patient sample.2.Raised the flapper for the capillary.3 started measurements but a calibration was started at same time.As result sample was aspirated but the result didn't appear also only the calibration data was recoded.
Additional Manufacturer Narrative
Radiometer investigations showed the product is found to be working as intended, no fault is found.Therefore, this incident does not meet the criteria for a reportable mdr.

• 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: anette gram ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22296007
• Report Number: 3002807968-2025-00081
• Device Sequence Number: 21065308
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2787N046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 07/18/2025

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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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