ISE 9180
Received Nov 25, 2008 · Event occurred Nov 12, 2008
Report 1823260-2008-08730 · MDR key 1249823
Device
Generic name
Blood Gas Analyzer - Jfp
Manufacturer
Roche DiagnosticsModel number
ISE 9180Catalog number
03157334001
Product problems
- Low Test Results
Patient
UNK
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CUSTOMER WAS RUNNING SAMPLES AS PART OF TROUBLESHOOTING A PROBLEM WITH CONTROL RECOVERY FOR LITHIUM AND SODIUM ASSAYS WHEN THEY RECEIVED DISCREPANT CALCIUM RESULTS FOR ONE PT SAMPLE. THE CALCIUM ASSAY WAS NOT IN QUESTION DURING THE TROUBLESHOOTING AND WAS RUN BECAUSE THE USER NEEDED THE CALCIUM RESULTS. AFTER RUNNING THE SAMPLES, THE CUSTOMER THEN QUESTIONED THE CALCIUM RESULTS SINCE THEY HAD ALREADY DETERMINED THE LITHIUM AND SODIUM ASSAYS WERE NOT WORKING PROPERLY BASED UPON QUALITY CONTROL RESULTS. THE PT SAMPLE WAS RUN SIX TIMES GIVING THE FOLLOWING CALCIUM RESULTS: 5.22, 5.20. 5.14, 5.06, 3.94 AND 5.15 MG/DL. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.