MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-801

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

The case is reported, due to precautionary reasons, as no data is available yet in this case.

Event Description

According to the complaint received, a customer experienced that a met ii cleaning measured too low on the high crea check on an abl800 analyzer.When they changed bottle the analyzer changed from status red to status green before the high crea check had been run.The customer does not know if this reflects that the analyzer can go directly into status green without running a check that verifies that the issue might have been solved, hereby reflecting an error on the analyzer.No data has been received yet in this case, so it cannot be rejected that the analyzer might have malfunctioned during this event.

Manufacturer Narrative

In initial mdr 3002807968-2018-00067 an incorrect udi code was stated.This has now been corrected in field d4 of this report.

Manufacturer Narrative

The failed qc reported by the customer concerns a high crea check at the level above 1500 mmol/l.The situation can only occur for this special high crea qc and not other qcs.Radiometer was able to reproduce the situation explained by the customer by using the customer configurations.The customer has changed the default settings from radiometer settings.To conclude, it is, verified that the analyzer does work as designed.

Manufacturer Narrative

Based on the investigation performed by radiometer, no malfunction of the analyzer was detected in this case.The analyzer worked as intended.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8183678
• MDR Text Key: 131000159
• Report Number: 3002807968-2018-00067
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: 05700693938004
• 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,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-801
• Device Catalogue Number: 393-801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1