ARCHITECT C-PEPTIDE REAGENT

Description of Event or Problem

FALSELY ELEVATED ARCHITECT C-PEPTIDE RESULTS OF 16.91 NG/ML WERE GENERATED FOR A (B)(6) FEMALE DIABETIC TYPE I PATIENT WITH CHRONIC THYROIDITIS. DUE TO THE ELEVATED RESULT, THE PATIENT SAMPLE WAS RETESTED WITH THE PRESTO II METHOD, WHERE A RESULT OF 0.0 WAS GENERATED(UNKNOWN UNITS OF MEASURE). THE ARCHITECT C-PEPTIDE RESULT WAS NOT REPORTED OUT OF THE LAB, THEREFORE, THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

(B)(4). THE CAUSE OF THE ARCHITECT C-PEPTIDE FALSELY ELEVATED QUALITY CONTROL 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.