PREA PREALBUMIN

Additional Manufacturer Narrative

FURTHER INVESTIGATION WAS NOT ABLE TO DETERMINE A ROOT CAUSE. THERE HAVE NOT BEEN ADDITIONAL SERVICE VISITS RELATED TO THE ISSUE.

Additional Manufacturer Narrative

BASED ON REVIEW OF THE PROVIDED CALIBRATION TRACE, MULTIPLE CALIBRATIONS WERE ACCOMPANIED WITH DATA FLAGS. REVIEW OF THE PROVIDED DATA DID SHOW THAT THE QUALITY CONTROL WAS AT THE UPPER RANGE ON (B)(6) 2017.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THE CUSTOMER DISCOVERED QUESTIONABLE PREA PREALBUMIN (PAB) RESULTS HAD BEEN GENERATED WHEN THEY PERFORMED A REAGENT LOT CORRELATION. THE RESULTS USING THE PREVIOUS REAGENT LOT WERE HIGHER THAN THE RESULTS USING THAT REAGENT LOT AND A NEW REAGENT LOT FROM A DIFFERENT ANALYZER. OF THE DATA PROVIDED FOR TWO EXAMPLES, ONLY THE RESULTS FOR ONE EXAMPLE WERE DISCREPANT. THE INITIAL RESULT WAS 75 MG/DL WITH THE OLD REAGENT LOT. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2017, THE RESULT WAS 19 MG/DL FOR THE SAME SAMPLE WITH THE PREVIOUS REAGENT LOT AND WITH THE NEW REAGENT LOT ON A DIFFERENT ANALYZER. THE CUSTOMER CORRECTED THE RESULT ON (B)(6) 2017. THE CUSTOMER DID NOT KNOW OF ANY ADVERSE EVENT FOR THE PATIENT. THE PREVIOUS REAGENT LOT NUMBER WAS 19429601 WITH AN EXPIRATION DATE OF 31-JUL-2018. THE NEW REAGENT LOT NUMBER WAS 24913401 WITH AN EXPIRATION DATE OF 31-MAR-2019. THE FIELD SERVICE ENGINEER (FSE) COULD NOT FIND A CAUSE. HE CHECKED THE PROBE ADJUSTMENT AND RINSE MECHANISM FLUID LEVELS AND PERFORMED A PRECISION CHECK FOR PAB THAT WAS WITHIN SPECIFICATION. HE CALIBRATED AND RAN QUALITY CONTROL THAT WAS WITHIN SPECIFICATIONS.