COBAS 6000 C501MODULE
Received Mar 5, 2010 · Event occurred Jan 7, 2010
Report 1823260-2010-01423 · MDR key 1623002
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04745914001
Lot number
NA
Product problems
- High Test Results
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
THE USER FAILED A URINE PHOSPHORUS PROFICIENCY SURVEY FOR THREE SAMPLES. ALL RESULTS WERE IN MG/DL. REPEAT TESTING WAS PERFORMED (B) (6) 2010. SAMPLE 1 INITIAL RESULT WAS 191.40 WITH AN ACCEPTABLE RANGE OF 76.31- 121.91. THE REPEAT RESULT WAS 104.2. SAMPLE 2 INITIAL RESULT WAS 76.60 WITH AN ACCEPTABLE RANGE OF 28.69-45.85. THE REPEAT RESULT WAS 38.8. SAMPLE 3 INITIAL RESULT WAS 127.80 WITH AN ACCEPTABLE RANGE OF 57.63- 92.07. THE REPEAT RESULT WAS 79.0. THE USER DID NOT HAVE ANY ERRONEOUS PATIENT RESULTS OR COMPLAINTS FROM DOCTORS. THE PHOSPHORUS REAGENT LOT NUMBER WAS 616734. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A BLOCKED VALVE RESPONSIBLE FOR WASHING THE SAMPLE PROBE. HE REPLACED BOTH VALVE BANKS AND VERIFIED THE ANALYZER OPERATION BY SUCCESSFULLY PRODUCING ACCURATE AND PRECISE CALIBRATION AND CONTROLS.