CLINITEK STATUS+
Received Dec 14, 2018 · Event occurred Nov 29, 2018
Report 3002637618-2018-00135 · MDR key 8164902
Device
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SIEMENS ENGINEER EVALUATED THE INSTRUMENT AND DID NOT FIND ANY HARDWARE ISSUES BY RUNNING CHECK CASSETTE FIVE TIMES ALONG WITH ELECTRONICS AND TEST TABLE TESTING. THE QC RESULTS WERE IN THE EXPECTED RANGES. A SUCCESSFUL CORRELATION STUDY WAS RUN WITH FRESH POSITIVE AND NEGATIVE URINE SAMPLES. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSE NEGATIVE AND BORDERLINE URINE HCG RESULT FROM THE CLINITEK STATUS+ COMPARED TO A POSITIVE RESULT FROM A HOME PREGNANCY TEST AND FROM A NON-SIEMENS QUALITATIVE MANUAL TEST KIT. THE CUSTOMER STATED THAT THE PATIENT IS BELIEVED TO BE PREGNANT ALTHOUGH THERE WAS NO CONFIRMATORY SERUM TEST RUN. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.