MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX WITH ANALYZER

Model Number	393-800
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Output Problem (3005); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is between 03may2025 and 09may2025.
Event or Problem Description
According to the complaint, customer reported, that barcode patient id is misinterpreted by abl800 flex (serial number: (b)(6)).A 10-digit patient id is scanned (cpr#) but the last 2 digits are misread (02 instead of 10).Unfortunately, this patient id belongs to another person in the same region.It happened on these samples: (b)(6) 2025 kl.02:12.(b)(6) 2025 kl.07:42.(b)(6) 2025 kl.19:13.(b)(6) 2025 kl.07:29.The barcode format used were code128.
Additional Manufacturer Narrative
The radiometer investigation has concluded that problems with analyzer's barcode scanner, potentially causing a patient mix-up and therefore incorrect medical treatment.The issue with the cpr-number barcode mix-up at auh appears to be an isolated incident, as it has not been observed elsewhere.The problem has been traced to external the cipherlab 1090+ handheld barcode reader.Since patient labels are only scanned with the handheld barcode reader this issue has nothing to do with the integrated barcode scanner in the front of the analyzer.

• Brand Name: ABL800 FLEX WITH ANALYZER
• Common Device Name: ABL800 FLEX WITH 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: anette gram ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22050257
• Report Number: 3002807968-2025-00073
• Device Sequence Number: 18396686
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2436N006
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 07/11/2025

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: 05/09/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2017
• 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