MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth is estimated.
Event or Problem Description
According to the complaint, two glu results from identical sample measured by two abl800s are different completely.The result from the first analyzer (serial number 754r1522n001) is 18.7mmol/l, and the other is >60mmol/l.A comparison result on a siemens analyzer gave result of 53.64mmol/l.Based on the comparison result and patinet condition, the result of 18.7mmol/l is reported as false low.
Additional Manufacturer Narrative
Two glu results from identical sample measured by two abl800s were different.Measurements were above the test range for abl800 flex glucose measurements which are defined to 0.5 - 15 mm glucose.If measurements are outside abl800 flex test range (0.5 - 15 mm) the accuracy and precision of the measurement is not defined.Therefore, measurements above 15 mm can be different.The following is from the operators manual, abl800 flex: "if values outside the limits of the test range are needed, the institutions must define their own reportable range (chapter 3, installation and set up, section analysis setup, reportable range, topic in this manual) and establish and verify the performance characteristics within these ranges.".

• 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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22564079
• Report Number: 3002807968-2025-00100
• Device Sequence Number: 11738471
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R1522N001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/21/2025

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
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2013
• 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: 21 YR
• Patient Sex: Male
• Patient Weight: 55 KG