ARCHITECT C-PEPTIDE REAGENT

Additional Manufacturer Narrative

(B)(4). THE CAUSE OF THE ARCHITECT C-PEPTIDE FALSELY ELEVATED QUALITY CONTROLS AND PATIENT RESULTS WAS DUE TO A NEW ANTIBODY LOT USED IN THE MANUFACTURING OF THE C-PEPTIDE MICROPARTICLE AND/OR CONJUGATE REAGENTS. ABBOTT ISSUED A PRODUCT RECALL LETTER TO ALL CUSTOMERS WITH INSTRUCTIONS TO DISCARD AND DESTROY ANY REMAINING INVENTORY OF THE AFFECTED LOTS.

Description of Event or Problem

THE CUSTOMER OBSERVED A HIGHER THAN EXPECTED ARCHITECT C-PEPTIDE RESULT FOR A DIABETIC PATIENT WHICH WAS INCONSISTENT WITH THE PATIENT'S INSULIN VALUES. THE CUSTOMER STATED THE C-PEPTIDE QUALITY CONTROLS WERE WITHIN 1SD, HOWEVER, EXTERNAL CONTROLS WERE HIGH. THE CUSTOMER PERFORMED A SERIES OF DILUTIONS TO RULE OUT POSSIBLE HETEROPHILIC ANTIBODY INTERFERENCE AND THE RESULTS OBTAINED CONFIRMED THE INITIAL ELEVATED RESULT. THE CUSTOMER CALLED THE PATIENT TO COME BACK FOR A SECOND BLOOD DRAW (NO DATA PROVIDED) HOWEVER, THE CUSTOMER RECALIBRATED THE ASSAY BETWEEN THE FIRST AND SECOND BLOOD DRAW WITH NO CHANGE IN THE CONTROL VALUES. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.