MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Codes	High Readings (2459); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, the customer has experienced intermittent erroneous high na patient results on the abl800 flex analyzer.When a sample is rerun on the biochemistry analyzer (architect) the results are within normal limits and more in line with the previous days results from the patient.(e.G.137mmol/l on architect, 154mmol/l radiometer abl827) this has happened on 4 different patients, all after the analyzer passed the internal qc and calibrations.(b)(6).
Additional Manufacturer Narrative
The radiometer investigation has shown a leakage into the measurement chamber around reference membrane on the abl800 flex analyzer.Investigation is ongoing.
Event or Problem Description
In the initial mdr report two timestamps and the related measurements of na were not correct.The correct results and timestamps are as follows: (b)(6) 2021 11:01, na, 156.(b)(6) 2021 13:06, na, 167.(b)(6) 2021 13:10, na, 165.(b)(6) 2021 13:13, na, 167.(b)(6) 2021 18:48, na, 152.
Additional Manufacturer Narrative
The radiometer investigation has shown that the high cna+ results were probably related to the detected leakage of blood into the reference chamber, but the precise failure mode has not been determined.
Additional Manufacturer Narrative
The radiometer investigation is finalized and the root cause is concluded to be 'supplied materials outside specification'.

• 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: anders nørregaard ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12914719
• Report Number: 3002807968-2021-00061
• Device Sequence Number: 5645441
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R2214N001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup,Followup
• Report Date (Section B): 04/21/2022

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: 11/22/2021
• Supplement Date Received by Manufacturer: 12/23/2021; 01/18/2022; 03/25/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/12/2022; 02/09/2022; 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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