CLINITEK STATUS+
Received Jan 11, 2019 · Event occurred Dec 17, 2018
Report 3002637618-2019-00006 · MDR key 8241584
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
TO ASSIST IN TROUBLESHOOTING, THE CUSTOMER WAS ASKED TO: RUN CONTROLS: BOTH LEVELS WERE IN THE EXPECTED RANGES. CLEAN TEST TABLE: WAS CLEAN. DIPPING TECHNIQUE WAS REVIEWED: PRESS START, DIP, RIM AND BLOT - TECHNIQUE WAS CORRECT. USE ANOTHER LOT OF MULTISTIX 10 SG: SAME RESULTS - FALSE NEGATIVE. THE CUSTOMER STATED THAT THEY HAVE NOT HAD ANY FURTHER DISCREPANCIES. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED FALSE NEGATIVE LEUKOCYTE RESULTS ON THE CLINITEK STATUS+ WHEN COMPARED WITH THE RESULTS OF A VISUAL READ OF MULTISTIX 10 SG AND FROM A NON-SIEMENS REFERENCE LAB. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.