OtherCCE
ABL800 SERIES
Received Jun 19, 2006 · Event occurred May 16, 2006
Report 3002807968-2006-00030 · MDR key 730804
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AFTER TREATMENT OF FOUR PATIENTS BASED ON MEASUREMENTS FROM THE BLOODGAS ANALYSER ABL825, IT WAS OBSERVED THAT ALL THE FOUR MEASUREMENT RESULTS USED FOR THE TREATMENT, WERE IDENTICAL WITH THE MEASUREMENT CONDUCTED JUST BEFORE THE MEASUREMENTS OF THE FOUR PATIENTS. NO HARM TO THE PATIENTS HAS BEEN REPORTED. THE PROBLEM IS CAUSED BY A SW BUG.