COBAS INTEGRA 800

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE CALCIUM RESULTS ON THEIR INTEGRA 800 ANALYZER. THE CUSTOMER PROVIDED DATA FOR FIVE PATIENTS WITH DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER REPEATED THE SAMPLES ON ANOTHER INTEGRA 800, SERIAL NUMBER (B)(4). THE CUSTOMER THEN REPEATED THE SAMPLES ON THE FIRST INTEGRA 800 ANALYZER USING A NEW CALCIUM CASSETTE. THE FIRST REPEAT RESULTS WERE ISSUED AS CORRECTED REPORTS. THE FIRST PATIENT'S INITIAL CALCIUM RESULT WAS 13.0 MG/DL. THE FIRST REPEAT RESULT WAS 7.0 MG/DL. THE SECOND REPEAT RESULT WAS 7.3 MG/DL. THE SECOND PATIENT'S INITIAL CALCIUM RESULT WAS 13.3 MG/DL. THE FIRST REPEAT RESULT WAS 9.6 MG/DL. THE SECOND REPEAT RESULT WAS 9.8 MG/DL. THE THIRD PATIENT'S INITIAL CALCIUM RESULT WAS 12.0 MG/DL. THE FIRST REPEAT RESULT WAS 9.5 MG/DL. THE SECOND REPEAT RESULT WAS 10.6 MG/DL. THE FOURTH PATIENT'S INITIAL CALCIUM RESULT WAS 12.1 MG/DL. THE FIRST REPEAT RESULT WAS 9.5 MG/DL. THE SECOND REPEAT RESULT WAS 9.9 MG/DL. THE FIFTH PATIENT'S INITIAL CALCIUM RESULT WAS 12.8 MG/DL. THE FIRST REPEAT RESULT WAS 8.3 MG/DL. THE SECOND REPEAT RESULT WAS 9.0 MG/DL. THERE WERE NO ADVERSE EVENTS. THE CALCIUM REAGENT LOT NUMBER WAS 64932001 AND THE EXPIRATION DATE WAS 03/31/2012. THE FIELD SERVICE REPRESENTATIVE FOUND LOOSE FITTINGS ON THE REAGENT PROBE. HE TIGHTENED ALL THE PROBES. THE ANALYZER WAS RUNNING TO SPECIFICATION. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL. THE CUSTOMER WAS SATISFIED WITH THE QUALITY CONTROL RESULTS.

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. SINCE THE QUALITY CONTROL WAS MEASURED WITHIN RANGE, THE LOOSE FITTINGS ON THE PROBES WERE NOT THE CAUSE. IT IS MORE PROBABLE THAT THE HIGH INITIAL CALCIUM RESULTS WERE DUE TO PRE-ANALYTIC ISSUES OR LACK OF MAINTENANCE.