CLIN CHEM ALBUMIN BCG REAGENT

Description of Event or Problem

THE CUSTOMER OBSERVED CLINICAL CHEMISTRY ALBUMIN BCG QUALITY CONTROL (QC) RESULTS OUT OF RANGE. THE CUSTOMER RECALIBRATED THE ALBUMIN ASSAY AND QC WAS IN RANGE, THEREFORE, THE CUSTOMER RE-ASSAYED PATIENT SAMPLES AND CORRECTED FOUR PATIENT REPORTS. THE CUSTOMER FAXED QC REPORTS AND CALIBRATION DETAILS FOR EVALUATION BY ABBOTT, HOWEVER, THE CUSTOMER DID NOT PROVIDE EXAMPLES OF THE FALSELY ELEVATED PATIENT RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL DEVICE: ARCHITECT C8000 ANALYZER, LIST # 1G06-01, (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative

(B)(4). ADVERSE EVENT OR PRODUCT PROBLEM, DESCRIBE THE EVENT OR PROBLEM: THE CUSTOMER SENT CALIBRATION DATA, (B)(4) DATA AND PATIENT DATA TO ABBOTT FOR EVALUATION AFTER THE CUSTOMER OBSERVED CLINICAL CHEMISTRY ALBUMIN BCG CONTROLS OUT OF RANGE. PATIENT SAMPLES WERE RE-RUN AFTER VERIFICATION OF ALBUMIN BCG CONTROLS IN RANGE. AN EXAMPLE OF THE PATIENT DATA IS AS FOLLOWS: PATIENT IDENTIFIER (B)(6): INITIAL RESULT: 3.3 G/DL, REPEAT RESULT: 4.5 G/DL REVIEW OF THE PATIENT DATA DETERMINED THE PATIENT REPORT WAS CORRECTED, AS THE INITIAL RESULT WAS REPORTED OUT OF THE LAB, HOWEVER, THERE WAS NO IMPACT TO PATIENT MANAGEMENT. CONCOMITANT MEDICAL PRODUCTS: ARCHITECT ANALYZER, LIST #1G06-01, SERIAL # (B)(4). THE CAUSE OF THE PARTICULATE MATTER (PENICILLIUM SP, A FUNGAL SPECIES FOUND IN THE ENVIRONMENT) OBSERVED IN SOME CLINICAL CHEMISTRY ALBUMIN BCG REAGENT CARTRIDGES WAS DUE TO EXPOSURE OF THE ALBUMIN BCG FORMULA CONTAINING WEAK ANTIMICROBIAL ADDITIVE FROM NORMAL FORMULATION AND FILTERING PROCESSES DESIGNED FOR MICROBIAL GROWTH CONTROLLED CLINICAL CHEMISTRY REAGENTS. ABBOTT ISSUED A PRODUCT RECALL ADVISING CUSTOMERS TO DISCARD OR DESTROY ANY INVENTORY OF THREE AFFECTED LOTS OF CLINICAL CHEMISTRY ALBUMIN BCG REAGENTS. ABBOTT IS IDENTIFYING ALTERNATE FORMULATION FOR THE CLINICAL CHEMISTRY ALBUMIN REAGENTS THAT CONTAIN NO MERCURY.