CLINITEK STATUS+
Received May 8, 2019 · Event occurred Apr 9, 2019
Report 3002637618-2019-00055 · MDR key 8593272
Device
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MET THE CLINICAL PICTURE AND A CORRECTED REPORT WAS ISSUED. PROPER MAINTENANCE AND TECHNIQUE WERE REVIEWED WITH THE CUSTOMER AND IT WAS FOUND THAT MAINTENANCE HAD NOT BEEN PERFORMED. THE CUSTOMER ACKNOWLEDGED THAT THE URINE STRIPS THAT THEY WERE USING WERE EXPIRED. THE CUSTOMER HAS NOT HAD ANY FURTHER DISCREPANCIES SINCE THEY REPLACED THE EXPIRED STRIPS.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSE NEGATIVE LEUKOCYTE RESULT ON THE CLINITEK STATUS+ WHEN COMPARED TO A VISUAL READ OF THE MULTISTIX 10-SG URINE STRIPS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.