URISYS 2400
Received Apr 15, 2009 · Event occurred Mar 20, 2009
Report 1823260-2009-02731 · MDR key 1437735
Device
Generic name
Automated Urine Analyzer - Jil
Manufacturer
Roche DiagnosticsModel number
U2400Catalog number
03051323001
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
UNK
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
USER EXPERIENCED TWO PT SAMPLES WHICH GENERATED RESULTS FOR ERYTHROCYTES FROM THE ANALYZER THAT DID NOT COMPARE WITH RESULTS FROM THE MICROSCOPIC EXAMINATION. THE FOLLOWING PT SAMPLE WAS DETERMINED TO BE DISCREPANT. INITIAL ERYTHROCYTE RESULT FROM ANALYZER WAS NEGATIVE. MICROSCOPIC EXAMINATION OF THE SAME URINE SAMPLE SHOWED 5 TO 10 RBCS PER HPF. SAMPLE WAS REPEATED ON THE ANALYZER GENERATING A NEGATIVE RESULT FOR ERYTHROCYTES. BOTH DIPSTICK AND MICROSCOPIC RESULTS WERE REPORTED FOR THIS PT SAMPLE. USER STATES THE PT WOULD NOT HAVE BEEN TREATED FOR THE NEGATIVE RESULT THAT WAS REPORTED ON THE DIPSTICK. THE USER DID NOT HAVE INFO AS TO WHETHER THE PT WAS ADVERSELY AFFECTED BY NOT RECEIVING TREATMENT.
Additional Manufacturer Narrative
ALTHOUGH THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO VERIFY THE PROBLEM, HE NOTED A PROBLEM WITH THE CALIBRATION AS A CAUSE. HE VERIFIED DEFAULT SETTINGS FOR REFLECTANCE, PERFORMED A CALIBRATION AND RAN CONTROLS TO VERIFY ANALYZER PERFORMANCE.