COBAS 6000 C501 MODULE
Received Sep 13, 2011 · Event occurred Aug 21, 2011
Report 1823260-2011-04834 · MDR key 2245100
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05860636001
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER RECEIVED ERRATIC CALCIUM RESULTS FOR THREE DAYS. THE CUSTOMER ISSUED EIGHT CORRECTED REPORTS, BUT PROVIDED DATA FOR ONE PATIENT WITH DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER NOTICED CALCIUM WAS RUNNING "7 SOMETHING" AND REPEATING "9 SOMETHING". THE PATIENT'S INITIAL CALCIUM RESULT WAS 4.0 MG/DL AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON A STANDALONE C501. THE REPEAT RESULT WAS "6 SOMETHING". THE CUSTOMER DEEMED THE "6 SOMETHING" RESULT WAS CORRECT AND IT WAS ISSUED AS A CORRECTED REPORT. NO PATIENTS WERE ADVERSELY AFFECTED BY THIS EVENT. THE CALCIUM REAGENT LOT NUMBER WAS 64585701 AND THE EXPIRATION DATE WAS 12/31/2011. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE EVENT WAS CAUSED BY FLUIDICS FAILURE DUE TO POOR CELL WASH AND CONTAMINATION IN THE ANALYZER WATER LINES. HE ADJUSTED ALL FLUIDICS DISPENSES AND PRESSURES. HE DID A COMPLETE DECONTAMINATION OF THE ANALYZER. A PATIENT COMPARISON WAS PERFORMED BETWEEN THE C6000 AND THE STANDALONE C501 WITH MATCHING RESULTS. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL WITH ALL RESULTS WITHIN RANGE.
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.