ACCESS VITAMIN B12 REAGENT

Additional Manufacturer Narrative

FULL PATIENT IDENTIFIER IS CASE-(B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS B12 REAGENT WAS NOT RETURNED FOR EVALUATION. ASSAY AND SYSTEM VERIFICATIONS SUCH AS CALIBRATION AND SYSTEM CHECK MET SPECIFICATIONS AT THE TIME OF THE INCIDENT. NO HARDWARE ERRORS OR FLAGS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. REVIEW OF THE CUSTOMER-PROVIDED PATIENT SAMPLE RESULT INFORMATION DEMONSTRATES THAT THE RESULTS SET DOES NOT MEET ASSAY PRECISION CLAIMS. IT WAS NOTED THAT THE RESULTS SET OF 88.5 PG/ML, 53 PG/ML AND 53.1 PG/ML WERE OBTAINED FROM REAGENT PIPETTOR 1 AND THE RESULT OF 266.4 PG/ML WAS OBTAINED FROM REAGENT PIPETTOR 3. CUSTOMER-PERFORMED PRECISION STUDIES DEMONSTRATED THAT PRECISION TESTING ON EACH INDIVIDUAL PIPETTOR MET ASSAY PRECISION CLAIMS. THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

Description of Event or Problem

ON 01NOV2019 THE CUSTOMER REPORTED THAT ON (B)(6) 2019, NON-REPRODUCIBLE ERRATIC VITAMIN B12 (ACCESS VITAMIN B12) RESULTS HAD BEEN GENERATED ON THE CUSTOMER'S UNICEL DXI800 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4) FOR ONE PATIENT SAMPLE. AN INITIAL SAMPLE RESULT OF 88.5 PMOL/L WAS OBTAINED ON (B)(6) 2019 AT 1436; THE SAMPLE WAS REPEAT TESTED AND A RESULT OF 266.4 PMOL/L WAS OBTAINED AT 1520. THE SAMPLE WAS REPEAT TESTED TWO MORE TIMES AND RESULT OF 53.0 PMOL/L AND 53.1 PMOL/L WERE OBTAINED AT 1825 AND 1826, RESPECTIVELY. THE SAMPLE WAS ALSO TESTED ONE TIME ON THE CUSTOMER'S ALTERNATE UNICEL DXI800 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4) ON (B)(6) 2019 AT 1726 AND A RESULT OF 66.8 PMOL/L WAS OBTAINED. THE CUSTOMER DID NOT INDICATE WHETHER ANY OF THESE RESULTS WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO PATIENT CARE OR TREATMENT. SYSTEM CHECK AND CALIBRATION WERE PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. QUALITY CONTROL INFORMATION WAS REQUESTED BUT NOT PROVIDED FOR REVIEW. INFORMATION REGARDING PATIENT SAMPLE COLLECTION AND PROCESSING WAS NOT PROVIDED.