MalfunctionCCE
ABL700 SERIES
Received Jul 11, 2006 · Event occurred Jun 13, 2006
Report 3002807968-2006-00034 · MDR key 770137
Device
Product problems
- Complete Blockage
- Other (for use when an appropriate device code cannot be identified)
- Incorrect Or Inadequate Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
WHEN USING AN ABL720 BLOOD GAS ANALYZER WRONG PH-VALUES WERE MEASURED. THE WRONG VALUES WERE CAUSED BY A CLOT IN THE PH MEASURING CHAMBER. ACCORDING TO OUR INTERNAL GUIDELINE VE.KVA.0029, ALL MEASUREMENT ERRORS BECAUSE OF CLOTS ARE REPORTABLE.