THE CUSTOMER REPORTED OBTAINING AN ERRONEOUS VITAMIN B12 RESULT FOR ONE PATIENT SAMPLE ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE INITIAL RESULT OBTAINED WAS >1500 PG/ML, WHICH WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS EXPECTED TO BE WITHIN THE NORMAL REFERENCE RANGE FOR VITAMIN B12. THE SAMPLE WAS DILUTED 1:5 AND RE-ANALYZED ON THE SAME INSTRUMENT, WHICH YIELDED 453 PG/ML, WHICH WAS IN THE NORMAL REFERENCE RANGE. THERE IS NO REPORT OF PATIENT INJURY OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE SAMPLE WAS CENTRIFUGED AT 3000 RPM FOR 8 MINUTES. SYSTEM CHECK PASSED ON (B)(4) 2014. THE CUSTOMER SENT THE PATIENT SAMPLE TO BECKMAN COULTER FOR SAMPLE INTERFERENCE TESTING. REFERENCE RANGE FOR ACCESS VITAMIN B12: 180 - 914 PG/ML.
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Patient 1
THE CUSTOMER DID NOT PROVIDE THE PATIENT'S WEIGHT. THERE IS NO INDICATION THAT THE ACCESS VITAMIN B12 REAGENT USED BY THE CUSTOMER WAS RETURNED FOR EVALUATION. BECKMAN COULTER ANALYSIS OF THE PATIENT SAMPLE INDICATED EVIDENCE OF ALKALINE PHOSPHATASE (ALP) INTERFERENCE, AS VITAMIN B12 WAS REDUCED BY 74% WITH THE ADDITION OF ALP BLOCKER. THE INSTRUCTIONS FOR USE FOR ACCESS VITAMIN B12 DOES NOT INCLUDE A LIMITATION FOR ALP INTERFERENCE.