InjuryCIT
INSTRUMENT: COBAS C311
Received Nov 9, 2010 · Event occurred Sep 27, 2010
Report MW5018171 · MDR key 1899774
Device
Generic name
None
Product problems
- Nonstandard Device
- High Test Results
Patient
50 YR
- No Information
Narrative
Description of Event or Problem
APPARENTLY THE CALCIUM REAGENT WAS THE ISSUE AS NO OTHER LAB RESULTS WERE IMPACTED, (A SPECIFIC LOT#) WAS RECALLED AND WE WERE NOT NOTIFIED. THE LAB MACHINE REPORTED 3 HIGH CALCIUM LEVELS ON PT CAUSING US TO NOTIFY COMPANY.