ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM WITH THE INSTRUMENT OR REAGENT. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE CUSTOMER'S LEVEL 2 OF QUALITY CONTROL WAS NOT ACCEPTABLE ON THE DAY OF THE EVENT. THE CUSTOMER WAS NOT PERFORMING ANALYZER MAINTENANCE (LIQUID FLOW CLEANING) AS REQUIRED. PER PRODUCT LABELING FOR THE ASSAY: FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS. THE RECOMMENDED 1:2 DILUTION WAS NOT PERFORMED AS THE CUSTOMER'S INTERNAL PROTOCOL IS TO NOT DILUTE VITAMIN B12 SAMPLES AS THEY DO NOT CONSIDER IT CLINICALLY RELEVANT. THE ANALYZER ALARM TRACE SHOWED THAT FOAM WAS DETECTED ON A SAMPLE ON THE DATE OF THE EVENT. THEREFORE SAMPLE QUALITY ISSUES MAY BE PRESENT AT THE CUSTOMER SITE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF HIGH VITAMIN B12 G2 ELECSYS RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT SERIAL NUMBER (B)(4) FOR 1 PATIENT WHICH REPORTEDLY LED TO A BONE MARROW ASPIRATION. THE INITIAL RESULT WAS REPORTEDLY 1476 PMOL/L WITH A DATA FLAG AND WAS REPORTED OUTSIDE OF THE LABORATORY. A NEW SAMPLE WAS DRAWN AND THE RESULT WAS REPORTEDLY 1476 PMOL/L WITH A DATA FLAG. AFTER THE FIRST RESULTS, A BONE MARROW ASPIRATION WAS REPORTEDLY PERFORMED TO TRY TO UNDERSTAND THE PATHOLOGY. THE ASPIRATION ALLEGEDLY "WENT WELL AND THE RESULT WAS OK". ON (B)(6) 2023, ONE OF THE SAMPLES WAS RETESTED AT AN EXTERNAL LABORATORY ON A COBAS E801 ANALYZER AND THE RESULT WAS <111 PMOL/L. ON (B)(6) 2023, THE OTHER SAMPLE WAS RETESTED ON A COBAS E801 ANALYZER AT THE EXTERNAL LABORATORY AND THE RESULT WAS <111 PMOL/L. ALLEGEDLY, THE PATIENT WOULD HAVE BEEN TREATED WITH B12 SUPPLEMENTATION INSTEAD OF UNDERGOING A BONE MARROW ASPIRATION.