OtherCDM
CLINITEK ADVANTUS
Received Jan 22, 2013 · Event occurred Dec 3, 2012
Report 1217157-2012-00080 · MDR key 2931384
Device
Product problems
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
CUSTOMER REPORTS THEY HAD NEVER CLEANED THE SYSTEM. CUSTOMER WAS PROVIDED INSTRUCTION ON PROPER CLEANING AND MAINTENANCE OF THE SYSTEM. CUSTOMER WAS SENT NEW LOT OF TEST STRIPS AND WILL PERFORM CORRELATION STUDY. MFR AWAITING RESULTS.
Description of Event or Problem
CUSTOMER REPORTS FALSE NEGATIVE LEUKOCYTE RESULTS ON A SAMPLE WHICH, UPON MICROSCOPIC EXAM, IS 2+ POSITIVE FOR LEUKOCYTES. NO REPORT OF INJURY WITH THE EVENT.