CLINITEK STATUS+
Received Apr 15, 2024 · Event occurred Mar 14, 2024
Report 3002637618-2024-00040 · MDR key 19112487
Device
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT THE REAGENT IS NOT AVAILABLE FOR RETURN, THEREFORE AN INVESTIGATION CANNOT BE PERFORMED. SIEMENS HAS REVIEWED THE CERTIFICATE OF ANALYSIS FOR THE REAGENT LOT IN USE AT THE TIME OF THE EVENT AND THE PRODUCT MET AND PASSED ALL SPECIFICATIONS UPON MANUFACTURING RELEASE. THE CAUSE OF THIS EVENT IS UNKNOWN.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED MORE INFORMATION AND TO SEE IF THE CUSTOMER IS ABLE TO SEND BACK ANY MATERIALS FOR INVESTIGATION. INVESTIGATION WILL COMMENCE ONCE THE REQUESTED DATA HAS BEEN RECEIVED. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE LEUKOCYTE RESULT ON THEIR CLINITEK STATUS+ INSTRUMENT COMPARED TO RETESTING ON THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
IT HAS BEEN IDENTIFIED THAT THIS COMPLAINT WAS DOCUMENTED WITH THE WRONG ¿BECOME AWARE¿ DATE. INVESTIGATION INTO THE TIMELINE OF THE TICKET SHOWED THAT THE TRUE AWARENESS DATE WAS MARCH 18, 2024.