MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number 393-090

Device Problem High Readings (2459)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

According to the complaint, on may 16th, when the customer measured patient blood sample on an abl90 flex analyzer (sn; (b)(6) ) in icu, the po2 result was 83.4 mmhg, which is higher than expected value.Then they measured the same sample again on another abl90 flex analyzer (sn; (b)(6) ) in ope, the second po2 result was 56.7 mmhg.Based on the patient's condition, the second po2 result for 56.7 mmhg was expected value.Therefore, the customer reported that the first po2 result for 83.4 mmhg was false high.

Manufacturer Narrative

Investigation is finalized, with the conclusion that the product did not malfunction.Most probable cause is a pre-analytical error with the sample, causing air to be introduced into to analyzer or within the sample before aspiration.

• Brand Name: ABL90 FLEX ANALYZER
• Type of Device: ABL90 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: cecilie jensen ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 17018534
• MDR Text Key: 316107215
• Report Number: 3002807968-2023-00022
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0869N043
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092686
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• 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