MalfunctionJHJ
CLINITEK STATUS
Received Apr 2, 2018 · Event occurred Mar 18, 2018
Report 7388068 · MDR key 7388068
Device
Generic name
Analyzer, Human Chorionic Gonadotropin
Manufacturer
Siemens Healthcare Diagnostics, Inc.Product problems
- Incorrect Or Inadequate Test Results
Patient
17 YR
- No Information
- No Information
Narrative
Description of Event or Problem
THE CLINITEK URINE ANALYZER USED TO CHECK URINE FOR POINT-OF-CARE TESTING (POCT) HAD A POSITIVE RESULT. THE SERUM TEST USED TO CHECK HAD RESULTS OF < 1 MIU/ML. THE URINE TEST WAS REPEATED SHOWING BORDERLINE RESULTS. ANOTHER MACHINE USED SHOWED NEGATIVE RESULTS.