MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number 393-801

Device Problem Low Test Results (2458)

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

Event Date 02/25/2019

Event Type  malfunction  

Event Description

The customer complains that the abl800 analyzer reports results for ccrea which are lower that results reported by their cobas analyzer.According to the customer the blood sample gives a result between 79 and 83 mmol/l on abl800 and 112 and 114 on cobas.

Manufacturer Narrative

At an internal review performed on 2019-09-20 it was found that b1 incorrectly was ticked off as an adverse event.This is corrected to product problem with this report.

• Brand Name: ABL800 FLEX ANALYZER
• Type of Device: ABL800 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8416481
• MDR Text Key: 138806880
• Report Number: 3002807968-2019-00006
• Device Sequence Number: 1
• Product Code: CHL
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-801
• Device Catalogue Number: 393-801
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1