MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX

Model Number 393-090

Device Problem Computer Software Problem (1112)

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

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

When the complaint was escalated to radiometer the described event was assessed not reportable to fda, as it was considered that the abl90 flex analyzer worked as intended with no malfunction and the user should have closed the inlet according to instructions to avoid the event.According to the investigation conclusion from the finalized rmed investigation verified on the 21jun2021 the abl90 flex software did fail to meet its specifications.The patient demographics from a previous sample goes into a new sample, which by rmed investigator has been categorized as patient data mix-up with cause traced to device design e.G.Inadequate software design.The previous sample is aborted due to "open inlet", but the analyzer does not go into oir and next sample does not query for patient demographics.

Event Description

According to the complaint after patient demographic query was success, sample measurement was aborted with error "inlet was open".Then sample was measured without query, patient information which was received for previous aborted sample was entered.The customer found this issue around apr.23.The device was not used for treatment or diagnosis during incident.The customer found this issue during checking procedure of measuring samples.

Manufacturer Narrative

Further radiometer investigation of the described event has led to correction in root cause as the event did in fact happen due to the user not following label instructions (including notification on the analyzer screen).The abl90 flex analyzer worked as intended with no malfunction identified and the root cause is therefore corrected to use error.

• Brand Name: ABL90 FLEX
• Type of Device: ABL90 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12194827
• MDR Text Key: 262472869
• Report Number: 3002807968-2021-00029
• 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
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• 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
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1