MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number 393-092

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Event Description

According to the complaint, a customer transferred blood from a syringe to two separate capillary tubes and ran the blood samples on an abl835 analyzer and on an abl90 flex plus analyzer.The customer reported that there were a significant difference between results from the two analyzers on the pco2, thb, k and glucose results.The customer obtained the following results: (b)(6).The customer stated that the results from the abl835 analyzer more accurately reflected the patient's condition.Later on the same day, a field service engineer visited the site and ran two blood samples on the same analyzers although the results were not as discrepant as the results obtained by the customer.

Manufacturer Narrative

The handling of the small sample from a syringe to a capillary in combination with a small clot is probably the explanation between the discrepant results between the two analyzers.It was most likely a preanalytical error which caused the problem.This case is considered closed by radiometer medical aps.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Type of Device: ABL90 FLEX PLUS ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7337403
• MDR Text Key: 102340935
• Report Number: 3002807968-2018-00014
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K160153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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
• Device Operator: No Information
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 04/11/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1