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 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

Radiometer is currently investigating the root cause of this event.As the discrepancy relates to results from a third part analyzer and not the true value of the sample, the size of the discrepancy can't be precisely determined and the data provided by the customer does thus not confirm that the abl800 is measuring outside of specification.Qc measurements are within the limits specified in the fsca with radiometer ref.(b)(4).

Event Description

The customer complains that the abl800 analyzer reports results for ccrea which are 15 % to 24 % lower that results reported by their cobas analyzer.

Manufacturer Narrative

At an internal review 2019-09-20, it was found that the udi number in this report was missing.It has been added in this report.

Manufacturer Narrative

The root cause to this event was not found.According to the customer, the analyzer is now running fine.

• 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: 8114826
• MDR Text Key: 128731246
• Report Number: 3002807968-2018-00064
• 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,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?: No
• 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: 10/31/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 02/19/2019; 09/20/2019
• Supplement Dates FDA Received: 03/01/2019; 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1