OtherCDM
CLINITEK ADVANTUS
Received Mar 25, 2013 · Event occurred Feb 28, 2013
Report 1217157-2013-00044 · MDR key 3031929
Device
Product problems
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTS FALSE NEGATIVE RESULTS FOR LEUKOCYTES ON THE INSTRUMENT AND AS WELL AS WHEN THE STRIP WAS READ MANUALLY (VISUALLY). MICROSCOPIC EXAM REVEALED 15-50 LEUKOCYTES PER FIELD. THERE WAS NO REPORT TO PT CARE AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE CAUSE FOR THE DISCORDANT SAMPLE IS UNK.