ISE 9180
Received Mar 12, 2010 · Event occurred Feb 23, 2010
Report 1823260-2010-01570 · MDR key 1629515
Device
Generic name
Blood Gas Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03157334001
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER RECEIVED ANALYZER ALARMS AND DISCREPANT LITHIUM RESULTS FOR ONE PATIENT SAMPLE. THE RESULTS WERE 1.02, 0.98, 0.94, 1.07, 0.85 AND 0.98 MMOL/L. THE PATIENT RESULTS WERE NOT REPORTED AND NO ACTIONS WERE TAKEN BASED ON THE RESULTS. THE LOT NUMBER OF THE LITHIUM ELECTRODE WAS NOT PROVIDED. INVESTIGATION DETERMINED THE CAUSE WAS A DEFECTIVE MAINBOARD AND REFERENCE VALVE WHICH WERE REPLACED. THE ANALYZER OPERATION WAS VERIFIED BY A SAMPLE SENSOR TEST, SERVICE TESTING, ADJUSTMENTS AND QC TESTING WITH ALL RESULTS PASSING.
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.