MalfunctionCDM
CLINITEK 500
Received Feb 5, 2013 · Event occurred Dec 13, 2012
Report 1217157-2013-00011 · MDR key 2997224
Device
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CUSTOMER STATES THAT AT LEAST 2 DIFFERENT LOT NUMBERS OF REAGENTS HAVE BEEN USED AND THAT MICROSCOPIC EXAMS ARE DONE ON ALL POSITIVE LEUKOCYTE RESULTS. CUSTOMER WILL ALSO PERFORM ANOTHER CORRELATION STUDY MAKING SURE TESTING IS DONE ON FRESH SAMPLES. THE CAUSE OF THE UNRECOVERED LEUKOCYTES IS NOT KNOWN.
Description of Event or Problem
CUSTOMER REPORTS THEY ARE PERFORMING CORRELATIONS FROM IRIS TO CT500 AND HAVE FOUND LEUKOCYTES ARE UNDER RECOVERING ON THE CT500. THERE WAS NO REPORT OF INJURY WITH THE EVENT.