ELECSYS PROBNP II IMMUNOASSAY

Additional Manufacturer Narrative

THE CUSTOMER RETURNED THE REAGENT PACK FOR INVESTIGATION. SECTIONS D9 AND H3 WERE UPDATED. THE CONTAINERS WERE CHECKED AND THERE WERE NO BROKEN OR LEAKY LIDS. THE REAGENT FLUID FROM THE TWO BOTTLES WAS COLORLESS AND TRANSPARENT, HOWEVER, THERE WERE SLIGHT PARTICLES OBSERVED IN ONE BOTTLE. THESE PARTICLES MAY HAVE CONTRIBUTED TO THE ISSUE, HOWEVER, THE ROOT CAUSE FOR THESE PARTICLES COULD NOT BE DETERMINED. THE INVESTIGATION RAN CALIBRATION AND QC ON THE RETURNED REAGENT PACK ON A COBAS 6000 E 601 MODULE AND CALIBRATION FAILED. THE CUSTOMER'S ISSUE (FAILED CALIBRATION) WAS REPRODUCED AT THE INVESTIGATION SITE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER RAN CALIBRATION AND QC ON BOTH REAGENT PACKS. QC RESULTS WERE OUTSIDE OF THE SPECIFIED RANGES AND CALIBRATION FAILED FOR THE REAGENT PACK IN QUESTION (SEQUENCE NUMBER (B)(4)). CALIBRATION AND QC WERE ACCEPTABLE FOR THE NEW REAGENT PACK (SEQUENCE NUMBER (B)(4)). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS USING A SPECIFIC REAGENT PACK FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PROBNP II (PROBNP II) ON A COBAS 8000 SYSTEM. THE INITIAL RESULT WAS 6434 PG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE PHYSICIAN. THE CUSTOMER REPLACED THE REAGENT PACK AND THE REPEAT RESULT WAS 58.77 PG/ML. THE 8000 SYSTEM SERIAL NUMBER WAS (B)(4).