CLINITEK ATLAS ANALYZER
Received May 21, 2014 · Event occurred Apr 21, 2014
Report 1217157-2014-00073 · MDR key 3825108
Device
Product problems
- False Positive Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SIEMENS FIELD SERVICE ENGINEER(FSE) WENT ON SITE AND CHECKED THE INSTRUMENT. THE INSTRUMENT WAS HAVING TROUBLE CALIBRATING AND WAS STRIPPING PADS OF THE REAGENT ROLL. DURING FSE INSPECTION, REAGENT DISPENSE MECHANISM WAS NOT LOCKED PROPERLY INTO PLACE WHICH CAUSED THE PADS TO DISPENSE IMPROPERLY AND STRIP PADS OFF. FSE ALIGNED THE MECHANISM PROPERLY TO WHICH INSTRUMENT PASSED CALIBRATION AND CONTROLS. INSTRUMENT IS OPERATIONAL ON FSE DEPARTURE.
Description of Event or Problem
CUSTOMER RECEIVED FALSE POSITIVES FOR UROBILINOGEN ON TWO PATIENT SAMPLES. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
(B)(4)