RAPIDPOINT 405
Received Oct 24, 2012 · Event occurred Sep 26, 2012
Report 1217157-2012-00053 · MDR key 2818470
Device
Generic name
Rapidpoint 405
Model number
405Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTS A DISCREPANT PCO2 RESULT. HOSPITAL POLICY REQUIRES A REPEAT FOR CRITICAL RESULTS. THE INITIAL PCO2 OF 75.4 WAS REPORTED. NO ACTION WAS TAKEN BASED ON THE REPORTED RESULTS FROM (B)(6) 2012 AT 12:19. THERE WAS NO IMPACT TO THE PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
QC WAS REPORTED IN RANGE FOR BOTH ANALYZERS. BOTH INSTRUMENTS WERE CALIBRATED AND QA WAS RUN AFTER CALIBRATION. QC WAS IN RANGE FOR ALL, BUT METHEMOGLOBIN. TRACE LOGS AND R1 FILES FOR (B)(6) 2012 WERE SUBMITTED TO THE MFR FOR BOTH ANALYZERS. CHANGING THE CARTRIDGE RESOLVED THE ISSUE. INITIAL COMPLAINT WAS SUSPECTED AS PRE-ANALYTICAL, AS THERE WERE NO SYSTEM CALIBRATION ISSUES.