CLINITEK STATUS+
Received Nov 18, 2019 · Event occurred Oct 8, 2019
Report 3002637618-2019-00123 · MDR key 9336633
Device
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- Pregnancy
- Pregnancy
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MET THE CLINICAL PICTURE AND A CORRECTED REPORT WAS ISSUED. SIEMENS REVIEWED CLEANING AND TECHNIQUE WITH THE CUSTOMER. SIEMENS HAS MADE THREE ATTEMPTS TO REACH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION AND TO REQUEST THE REAGENT CARTRIDGES BACK FOR INVESTIGATION. THERE HAS BEEN NO RESPONSE FROM THE CUSTOMER. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSE NEGATIVE URINE HCG RESULT. AN IUD WAS THEN IMPLANTED IN THE PATIENT. THE PATIENT LATER TOOK A HOME PREGNANCY TEST AND RECEIVED A POSITIVE RESULT. AN ULTRASOUND THEN SHOWED THE PATIENT TO BE 6.5 WEEKS PREGNANT AND THE IUD WAS REMOVED.