MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number 393-090

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2017

Event Type  malfunction  

Event Description

According to the complaint, the abl90 flex analyzer gave "wrong" results for glucose and lactate.Before the tests the analyzer was blocked with no reaction when tapping the screen.The customer (poct employee from laboratory) did reset the analyzer through the reset button on the back-site of the instrument.After startup all parameters were green.Customer measured two "old" blood samples from the trash can without any note, status still green.After a while the perfusionist measured a patient sample and noticed that the glucose and lactate results did not match the patient's condition.The same sample was then tested on an abl825 analyzer giving results that was in line with patient's condition.The following results were reported by the abl90 flex: glucose: 0,8 mmol/l, 0,9 mmol/l and 0,9 mmol/l.Lactate: 0,1 mmol/l, 0,1 mmol/l and 0,1 mmol/l.On the abl825 the same samples gave the following results: glucose: 4,8 mmol/l, 5,5 mmol/l and 7 mmol/l.Lactate: 0,8 mmol/l, 0,7 mmol/l and 1 mmol/l.Nobody was maltreated.

Manufacturer Narrative

It has been investigated why the analyzer in question froze.The service dump from the analyzer does not show any hints for the cause of this freeze.The freeze of the analyzer is the only possible way of triggering the issue for this complaint, which is the deviating metabolite measurements due to a warm start after the analyzer has been powered off with the sample left in the sensor cassette.The fix to the complaint is to commit chip data during measurements by persisting the sensor ready flag in the state file, which in combination with the sensor chip data will trigger a cold start.

Manufacturer Narrative

Within a two second interval after a sample is aspirated and before it is measured, the status of the analyzer's chip is updated.Because the abl800 analyzer software froze within these two seconds, the chip was not updated with the information that a measurement was performed.Due to this, the analyzer performed a "warm start" instead of a "cold start".A "warm start" is a faster startup procedure without all calibrations performed as in a "cold start".However, because the sensitivity of the sensor for glu and lac had been affected by being exposed to aspirated blood for a longer period a "cold start" was needed.This is what caused the discrepant results for glu and lac.The reason why the analyzer software froze is still being investigated.

• Brand Name: ABL90 FLEX ANALYZER
• Type of Device: ABL90 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 6766451
• MDR Text Key: 81944564
• Report Number: 3002807968-2017-00025
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K092686
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1