MalfunctionCCC
RAPIDPOINT 400
Received Mar 30, 1999 · Event occurred Mar 1, 1999
Report 1217157-1999-00001 · MDR key 217100
Device
Generic name
Blood Gas Analyzer
Manufacturer
Chiron Diagnostics Corp.Model number
NACatalog number
109824
Lot number
NA
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
NA
Narrative
Description of Event or Problem
CUSTOMER REPORTED UNDER-RECOVERY OF RAPIDQC COMPLETE QUALITY CONTROL MATERIAL FOR PARTIAL OXYGEN PRESSURE RESULTS. LEVEL 1 : ASSIGNED RANGE 134-156 MMHG; VALUES OBTAINED 126/127/130 MMHG; LEVEL 2: ASSIGNED RANGE 88-104; VALUES OBTAINED 83/85/97; LEVEL 3: ASSIGNED RANGE 12-34; VALUES OBTAINED 21/22. THIS INDICATED THAT THERE WAS POTENTIAL FOR UNDER-REPORTING PT VALUES FOR PARTIAL PRESSURE OF OXYGEN. IT IS BELIEVED THAT NO PT DATA WAS REPORTED.
Remedial action
- Notification
- Relabeling