MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number 393-090

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2019

Event Type  malfunction  

Event Description

According to the complaint received, observed deviation on the na+ and k+ parameter on an abl90 flex analyzer compared to the measurements from the central laboratory.The measurements are shown below, demonstrating a negative deviation of 9 mmol/l for na+ and negative deviation of 0.8 mmol/l for k+.On (b)(6) 2019 12:21 abl90 flex: na+ 128 mmol/l; (b)(6) 2019 12:21 abl90 flex: k+ 3.8 mmol/l; central laboratory: na+ 137 mmol/l; central laboratory: k+ 4.6 mmol/l.Based on the measurements listed, the customer reported the na+ and k+ result from the abl90 flex analyzer as false low.

Manufacturer Narrative

According to the root cause investigation performed it was not possible to conclude the root cause in this case.Most likely it was interference in the sample.

Manufacturer Narrative

The serial number of the analyzer (b)(6) has been added in field d4.Furhtermore, an incorrect udi number was stated in the initial mdr 3002807968-2019-00008, which now has been correct also in field d4.

• Brand Name: ABL90 FLEX ANALYZER
• Type of Device: ABL90 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8357376
• MDR Text Key: 141245137
• Report Number: 3002807968-2019-00008
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909
• Combination Product (y/n): N
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

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: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 04/16/2019; 09/23/2019
• Supplement Dates FDA Received: 04/30/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1