CLINITEK STATUS+

Additional Manufacturer Narrative

INITIAL INVESTIGATION LED TO A DISCUSSION ON HOW TO PROPERLY PERFORM MAINTENANCE AS IT APPEARS THE CUSTOMER WAS NOT PERFORMING MAINTENANCE AS RECOMMENDED. AFTER PERFORMING CORRECT MAINTENANCE, CUSTOMER REPORTED QUALITY CONTROL WAS PASSING. REAGENT IS BEING REQUESTED BACK FOR FURTHER INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

Description of Event or Problem

THE CUSTOMER OBTAINED FALSE NEGATIVE LEUKOCYTE RESULTS ON TWO PATIENTS 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

PROPER MAINTENANCE AND TECHNIQUE WERE REVIEWED WITH NO ISSUES. POSSIBLE INTERFERENTS THAT MAY CAUSE FALSE NEGATIVE LEUKOCYTES WAS REVIEW WITH THE CUSTOMER. THE CERTIFICATE OF ANALYSIS FOR LOT IN USE AT THE TIME OF THE EVENT WAS REVIEWED AND PASSED ALL SPECIFICATIONS UPON MANUFACTURING RELEASE. THE CUSTOMER RETURNED REAGENT TO SIEMENS FOR FURTHER EVALUATION. INVESTIGATIONAL TESTING WAS PERFORMED ON RETURNED REAGENT USING THREE TECHNICAL OPERATIONS OWNED STATUS + INSTRUMENTS. FOUR STRIPS WERE TESTED PER INSTRUMENT, USING WBC 42 CELL SOLUTION (0143-77 EXP 1/10/25) TO REPRESENT A POSITIVE LEUCOCYTE SOLUTION. NO DISCREPANT FALSE NEGATIVE RESULTS WERE OBTAINED; ALL 12 RESULTS WERE OBSERVED POSITIVE. BASED ON THE DATA COLLECTED, THE CUSTOMER¿S REPORT WAS NOT OBSERVED. THE CAUSE OF THIS EVENT IS UNKNOWN.