MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2018

Event Type  malfunction  

Event Description

According to the complaint, a patient sample measured on the abl800 analyzer (serial no.(b)(4)) gave a false high potassium result of 8.2 mmol/l compared to a laboratory analyzer result of 4.2 mmol/l.No reports of an adverse event has been received related to this case.The health care professional noticed the discrepancy between the high result and the patient's condition, and did not initiate treatment.

Manufacturer Narrative

The radiometer investigation of the available data showed the following: the results from the different parameters do not give a clear indication of hemolysis in the samples.Radiometer cannot find any deviation in the instrument, so we have not been able to determinate the root cause for the discrepant results.

Manufacturer Narrative

Investigation of data from the instrument did not show a deviation.Further data has been requested from the customer in order to continue the root cause analysis.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7812270
• MDR Text Key: 118095527
• Report Number: 3002807968-2018-00055
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754754R2322N007
• 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,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• 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
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other