CLINITEK ADVANTUS
Received Oct 21, 2019 · Event occurred Sep 23, 2019
Report 3002637618-2019-00113 · MDR key 9215846
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
20 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS AND A CORRECTED REPORT WAS ISSUED. THE CUSTOMER DECLINED TO SEND ANY MATERIALS FOR FURTHER INVESTIGATION. PROPER TECHNIQUE AND MAINTENANCE WERE REVIEWED WITH THE CUSTOMER AS WELL AS POSSIBLE CAUSES OF A FALSELY DEPRESSED LEUKOCYTE RESULT. THE CUSTOMER HAD NOT LUBRICATED THE PUSH BAR AS OFTEN AS RECOMMENDED AND ARE OPERATING AT A SLIGHTLY LESS THAN RECOMMENDED TEMPERATURE. SINCE THEY INSTALLED THE NEW FIXED PLATFORM AND LUBRICATED THE PUSH-BAR RAIL, THEY HAVE NOT HAD ANY FURTHER DISCREPANCIES. THE INSTRUMENT IS OPERATIONAL.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT LEUKOCYTE RESULTS ON THE CLINITEK ADVANTUS WHEN COMPARED TO THE MICROSCOPIC EXAMINATION OF THE URINE SEDIMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.