MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX,

Model Number	393-800
Medical Device Problem Codes	High Readings (2459); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint the customer is complaining about deviations on parameter ph, pco2 and po2 measured on the abl800 flex analyzer (serial no.(b)(6)).Values for ph, pco2 and po2 differ between two measurements from the same patient.The customer states that the values measured during the second measurement do not match with the patient's condition.Following table regarding the two measurements carried out: (b)(6).Based on the measurement results the results of 7,33 (ph) and 155 mmhg (po2) measured on the abl800 flex analyzer is considered false high.The 53,2 mmhg (pco2) is considered false low.At a follow up visit radiometer field service engineer cleaned the abl800 flex analyzer and replaced the po2 electrode and pco2 sealing ring and membrane, ph sealing ring and reference membrane.
Additional Manufacturer Narrative
Radiometer has finalized its investigation with the conclusion that the product did not malfunction.No measurement errors were present in either measurement of ph, pco2, po2 or any of the other.Furthermore, all calibrations as well as ac6+ results for ph, pco2 and po2 performed before and after the considered discrepant measurement passed, and nothing extraordinary is observed.

• 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: cecilie jensen ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 16842600
• Report Number: 3002807968-2023-00017
• Device Sequence Number: 7546990
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R2302N004
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/05/2023

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: 04/19/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2016
• 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: 62 YR
• Patient Sex: Female