MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX; ABL800 FLEX ANALYZER

Model Number 393-800

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  malfunction  

Event Description

According to the complaint, a customer obtained high potassium results for two different patients applying the abl800 flex analyzer.For the first patient, the result was 12 mmol/l.The sample was retested, however with high concentration of potassium.Subsequently, a different analyzer was applied giving a normal result (4 mmol/l) for potassium for a new blood sample.A 1-point calibration and a quality control was executed on the abl800 flex analyzer.Finally, another sample was tested in here giving a potassium result of 16 mmol/l.Based on these measurements, the customer reports the results of potassium from the abl800 flex analyzer as (b)(6).

Manufacturer Narrative

Radiometer medical aps was able to identify the root cause for the false high positive potassium results as being hemolysis of the sample due to a pre-analytical error.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7661832
• MDR Text Key: 113185317
• Report Number: 3002807968-2018-00049
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754754R0867N009
• Combination Product (y/n): N
• PMA/PMN Number: K041874
• 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: 09/20/2018

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: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/04/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1