CLINITEK STATUS+
Received May 22, 2025 · Event occurred Apr 30, 2025
Report 3002637618-2025-00037 · MDR key 22068085
Device
Generic name
Clinitek Status+
Catalog number
10379675
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE HCG RESULT ON THEIR CLINITEK STATUS+ INSTRUMENT COMPARED TO RETEST IN THE SAME DEVICE. THE PATIENT'S PREGNANCY WAS CONFIRMED FROM THE ULTRASOUND. THERE IS NO REPORTED INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
THE CUSTOMER HAS STATED THAT THEY WERE PERFORMING PROPER MAINTENANCE AND PASSING QUALITY CONTROLS. THE CUSTOMER COMMUNICATED THAT THEY DID NOT HAVE ANY REMAINING REAGENT AVAILABLE. WITHOUT THE RETURNED REAGENT, AN INVESTIGATION CANNOT PROCEED AND THEREFORE THE ROOT CAUSE CANNOT BE DETERMINED. THE DCU REVIEWED THE CERTIFICATE OF ANALYSIS FOR 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 IN UNKNOWN. NO PRODUCT PROBLEM IDENTIFIED.