CLINITEK STATUS+

Additional Manufacturer Narrative

SIEMENS SHOWED DUE DILIGENCE IN GETTING THE COMPLAINT REAGENT BACK FOR INVESTIGATION, HOWEVER, TO DATE, THERE HAVE NOT BEEN ANY INFORMATION REGARDING THE COMPLAINT REAGENTS AND NO OTHER INFORMATION HAS BEEN PROVIDED. WITHOUT THE RETURNED REAGENT, FURTHER INVESTIGATION CANNOT PROCEED AND THEREFORE THE ROOT CAUSE CANNOT BE DETERMINED. WITHOUT A FURTHER INVESTIGATION, THE CAUSE OF THE EVENT IS UNKNOWN. NO PRODUCT PROBLEM IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBTAINED FALSE NEGATIVE LEUKOCYTE RESULTS ON ONE PATIENT COMPARED TO RETESTING ON THEIR LABORATORY INSTRUMENT. REPEAT TESTING WAS PERFORMED FROM THE SAME SAMPLE. TIME BETWEEN TESTS WAS NOT PROVIDED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

Additional Manufacturer Narrative

INITIAL INVESTIGATION LED TO A DISCUSSION ON PROPER MAINTENANCE. THE CUSTOMER IS PERFORMING MAINTENANCE AS DESCRIBED IN THE OPERATOR'S GUIDE. THE CALIBRATION BAR WAS INSPECTED FOLLOWING THE EVENT AND APPEARED CLEAN AND NORMAL. PROPER TECHNIQUE WAS DISCUSSED AND CONFIRMED TO BE USED BY THE OPERATORS. QUALITY CONTROL (QC) IS RUN EVERY 30 DAYS. QC WAS PASSING PRIOR TO THE EVENT AND FOLLOWING THE EVENT. REAGENT IS BEING REQUESTED BACK FOR FURTHER INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.