CLINITEK STATUS+
Received Dec 22, 2022 · Event occurred Sep 19, 2022
Report 3002637618-2022-00080 · MDR key 16034006
Device
Generic name
Clinitek Status+
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
10379675Catalog number
10379675
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER INDICATED THAT INSTITUTING PROPER MAINTENANCE RESOLVED THEIR ISSUE. CUSTOMER IS OPERATIONAL AND HAS STATED THAT THEY WILL NOT PROVIDE ADDITIONAL INFORMATION ON THIS ISSUE. NO FURTHER INVESTIGATION POSSIBLE.
Additional Manufacturer Narrative
THE CUSTOMER HAS BEEN ASKED TO REVIEW MAINTENANCE AND TECHNIQUE AND HAS BEEN ASKED TO RUN A COMPARISON STUDY TO CONFIRM INSTRUMENT OPERATION. INVESTIGATION UNDERWAY. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED SEVERAL DISCREPANT LEUKOCYTE AND NITRITE RESULTS ON FOUR PATIENTS COMPARED TO RETESTING OF DIFFERENT SAMPLES ON A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.