MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX,

Model Number 393-800

Device Problems High Readings (2459); Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Event 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.

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,
• Type of Device: 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
• MDR Text Key: 314277255
• Report Number: 3002807968-2023-00017
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R2302N004
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female