ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2

Additional Manufacturer Narrative

THE COBAS 6000 C 501 SERIAL NUMBER WAS (B)(6) THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE INITIAL RESULT WAS 130 U/L. THIS RESULT WAS QUESTIONED AS IT DID NOT COMPARE TO THE PREVIOUS DAY'S RESULT. THE REPEAT RESULTS FROM ANOTHER COBAS C501 ANALYZER WERE 94 U/L AND 83 U/L. THE REPEAT RESULT FROM THE ORIGINAL COBAS C501 ANALYZER WAS 84 U/L. THIS RESULT WAS BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

THE PROVIDED CENTRIFUGATION SETTINGS WERE LOWER THAN RECOMMENDED BY THE TUBE MANUFACTURER. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THE ANALYZER ALARM TRACE DID NOT CONTAIN ANY CONSPICUOUS EVENTS. AS THE CALIBRATION AND QC WERE ACCEPTABLE, THERE IS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE CUSTOMER REPORTED NO FURTHER ISSUES. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.