MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2020

Event Type  malfunction  

Event Description

According to the complaint, the customer experienced that the abl800 analyzer linked a previous number with a new sample with another number.

Manufacturer Narrative

Radiometer has decided to initiate recall with radiometer ref.Fan 915-412 in order to correct the issue at all affected custtomers.The permanent countermeasure willl be a new software version where this issue is corrected.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 9859941
• MDR Text Key: 202533249
• Report Number: 3002807968-2020-00012
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3002807968-05/14/20-006
• Patient Sequence Number: 1