MalfunctionJFP
ISE 9180
Received Mar 21, 2008 · Event occurred Feb 26, 2008
Report 1823260-2008-02656 · MDR key 1019675
Device
Generic name
Blood Gas Analyzer - Jfp
Manufacturer
Roche DiagnosticsModel number
ISE 9180Catalog number
03157334001
Product problems
Patient
UNK
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
ACCOUNT EXPERIENCING GETTING ERRATIC PT RECOVERY FOR SODIUM STARTING 2007. NO PT RESULTS WERE PROVIDED. THE ONLY DATA PROVIDED WAS FROM A REPRODUCABILITY STUDY PERFORMED IN 2008, WHICH INCLUDED FOURTEEN SODIUM RESULTS FROM ONE PT SAMPLE. INITIAL RESULT GAVE 136 MMOL/L; SAMPLE REPEATED THIRTEEN TIMES GIVING 121, 135, 140, 137, 141, 138, 141, 132, 140, 111, 120, 137 & 132 MMOL/L. NO ADVERSE EVENTS REPORTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.