MalfunctionJIL
CLINITEK STATUS+
Received Jun 22, 2023 · Event occurred Jun 9, 2023
Report 3002637618-2023-00043 · MDR key 17182703
Device
Product problems
- False Negative Result
- False Negative Result
Patient
17 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER HAS NOT RETURNED THE REQUESTED MATERIALS. THE INSTRUMENT AND IMPACTED REAGENT LOT ARE NOT AVAILABLE, AN INVESTIGATION CANNOT BE PERFORMED. THEREFORE THE ROOT CAUSE CANNOT BE DETERMINED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT LEUKOCYTE RESULTS COMPARED TO CYTOBACTERIAL TESTING OF THE SAME SAMPLE ON A LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED MORE INFORMATION FOR FURTHER INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.