MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number 393-800

Device Problems High Readings (2459); Output Problem (3005)

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

Event Date 06/18/2023

Event Type  malfunction  

Event Description

According to the complaint at 12:09 on (b)(6) 2023, the customer measured a patient blood sample and the po2 result was 234 mmhg on an abl800 analyzer serial number: (b)(6), which was clearly higher than expected.Then, since they doubted the po2 result, they measured the same sample again at 12:18.The second result was 62,5mmhg which was almost expected value.Therefore, the customer considered that the first po2 result was false high.

Manufacturer Narrative

The radiometer investigation has not been able to identify a root cause for this case, hence the root cause remains unknown.No products were returned.

• Brand Name: ABL800 FLEX ANALYZER
• Type of Device: ABL800 FLEX 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: ditte krøyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 17265203
• MDR Text Key: 318931586
• Report Number: 3002807968-2023-00027
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/06/2023
• 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: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2011
• 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