CLINITEK STATUS+
Received Dec 5, 2018 · Event occurred Nov 12, 2018
Report 3002637618-2018-00132 · MDR key 8135618
Device
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SIEMENS REVIEWED MAINTENANCE AND CLEANING PROCEDURES WITH THE CUSTOMER. IN ADDITION, THEIR SAMPLE HANDLING AND PROCESS TECHNIQUE WERE REVIEWED. THERE WERE NO ISSUES FOUND. THE CALIBRATION BAR WAS RECENTLY CLEANED AS PER PROCEDURE. SIEMENS WILL PROVIDE THE CUSTOMER WITH A LOANER SYSTEM TO RUN A SIDE BY SIDE COMPARISON WITH THEIR OWN SYSTEM AND AN UPDATE WILL BE PROVIDED ONCE COMPLETED. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THREE PATIENTS WITH FALSE NEGATIVE AND ONE PATIENT WITH SMALL LEUKOCYTE RESULTS ON THE CLINITEK STATUS+ WHEN COMPARED TO THE MANUAL MICROSCOPY READING. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
AS STATED IN THE INITIAL REPORT - 3002637618-2018-00132: "SIEMENS WILL PROVIDE THE CUSTOMER WITH A LOANER SYSTEM TO RUN A SIDE BY SIDE COMPARISON WITH THEIR OWN SYSTEM." THERE IS NO INDICATION THAT THIS HAS BEEN DONE. AFTER SEVERAL INQUIRIES, THERE HAS BEEN NO RESPONSE FROM THE CUSTOMER REGARDING A SIDE BY SIDE COMPARISON. SIEMENS SERVICE WENT ONSITE AND REVIEWED PROPER MAINTENANCE AND TECHNIQUE WITH THE CUSTOMER. THE CUSTOMER WAS NOT USING PROPER TECHNIQUE. SIEMENS HAS PROVIDED FURTHER TRAINING FOR THIS CUSTOMER. THE CUSTOMER STATED THAT THEY FREQUENTLY HAVE URINE SAMPLES TOO SMALL FOR THE CORRECT DIPPING TECHNIQUE AND THEIR ONLY OPTION IS TO USE A DROPPER. SIEMENS HAS NO OFFICIAL RECOMMENDATIONS FOR USING A DROPPER TO APPLY THE SAMPLE TO THE STRIP. A REVIEW OF THIS LOT OF MUTISTIX 10 SG REAGENT HAS SHOWN NO SIMILAR COMPLAINTS.