MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number 393-092

Device Problems No Apparent Adverse Event (3189); Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

The date of event is unknown, and therefore, estimated as same date as awareness date 2020-08-19.The component code is chosen as 'appropriate term/code not available' as it currently is not known, which component that potentially may be affected this will be known when investigation has been completed.

Event Description

A customer complains that the short freeze occurring on an abl90 flex plus analyzer for about 30 seconds after running a sample, prior to the result being displayed, can lead to an incorrect patient id being entered.If the freeze occurs while users are entering patient demographics, this can cause issues with incorrect data being entered e.G.Temperature or sample type.There have been other instances, where this freezing occurs when the "confirm patient details" window is up, then the analyzer will move on from this step without the user confirming or declining the details.It is not something that occurs regularly, but the risk of wrong patient id is a serious concern for the department and the point-of-care-team.

Manufacturer Narrative

Based on the preliminary investigation of the data logs provided by the customer, it shows that the abl90 flex software doesn't work as expected.During a measurement the operator can type in patient information on the abl90 flex analyzer.Once the result is ready (beep sound is played and "result" button appears), the result is automatically shown ("short freeze" of 1-2 seconds) if there is no typing for 10 seconds.The result shall not be shown automatically as long as the operator types (without 10 seconds break).Radiometer has, howeever, observed that once the measurement completes (progress bar completes), the result is automatically shown regardless if operator is typing or not.This is not the expected behaviour of the abl90 flex software.The identification of the root cause for this behavior will be further investigated.

Manufacturer Narrative

Based on the investigation of this case radiometer has identified a software (sw) bug in the abl90 sw, whereby a result finalized will be shown to the operator even if the operator is still typing a patient id on the screen.Expected behavior should have been that the result first should be shown if the operator has not typed in 10 seconds.The analyzer can following request the patient demographics based on the incomplete patient id entered but the aqure system will only return patient information if an exact patient id match is found.The operator will be able to go back and complete the patient id immediately after the result is shown.The customer has informed that all patient ids are of a fixed length and all starts with 'x'.An evaluation of the customer data base showed that some number of patient ids in the database contain patient ids with 9 characters starting with 's', as well as some 'test eqa' patient ids with 7 characters starting with 'xxtest.Eqa'.Based on this data from the customer a patient mix-up can never happen as a patient id never will be returned from aqure based on an incomplete patient id number.The finalized investigation by radiometer has identified that the sw bug will most likely only cause inconvenience to the operator, as it cannot lead to a patient mix-up, why this case is no longer considered an adverse event by radiometer and therefore no longer meets the reporting requirements for submitting a mdr.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Type of Device: ABL90 FLEX PLUS ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 10613420
• MDR Text Key: 209390004
• Report Number: 3002807968-2020-00041
• Device Sequence Number: 1
• Product Code: MQM
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923
• Combination Product (y/n): N
• PMA/PMN Number: K160153
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1