ALINITY C MICROALBUMIN

Additional Manufacturer Narrative

A REVIEW OF COMPLAINTS FOR THE ALINITY C MICROALBUMIN ASSAY DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. FILE SAMPLE ANALYSIS WAS NOT PERFORMED AS THE ISSUE WAS FOUND TO BE THE URINE MICROALBUMIN ASSAY WAS CONFIGURED INCORRECTLY ON THE ALINITY C PROCESSING MODULE THE UNIT SHOULD BE CONFIGURED ON THE ANALYZER TO BE UG/ML OR MG/L, NOT MG/DL. THE PATIENT SAMPLES RESULTS WERE RECALCULATED AFTER CORRECTING THE ASSAY PARAMETERS AND RESULTS WERE AS EXPECTED WITH THE UNITS OF MEASUREMENT. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED THE URINE MICROALBUMIN ASSAY WAS CONFIGURED INCORRECTLY ON THE ALINITY C PROCESSING MODULE BY ABBOTT RESULTING IN FIVE PATIENT SAMPLES 10X HIGHER THAN PREVIOUS HISTORY. EXAMPLE RESULTS PROVIDED: SID (B)(6): RAW RESULT 0.769; RESULT REPORTED 7.6912 MG/DL. SID (B)(6): RAW RESULT: 17.618; RESULT REPORTED:176.1848 MG/DL. THE UOM SHOULD BE CONFIGURED ON THE ANALYZER TO BE UG/ML OR MG/L, NOT MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED THE URINE MICROALBUMIN ASSAY WAS CONFIGURED INCORRECTLY ON THE ALINITY C PROCESSING MODULE BY ABBOTT RESULTING IN FIVE PATIENT SAMPLES 10X HIGHER THAN PREVIOUS HISTORY. EXAMPLE RESULTS PROVIDED: SID (B)(6): RAW RESULT 0.769; RESULT REPORTED 7.6912 MG/DL SID (B)(6): RAW RESULT: 17.618; RESULT REPORTED:176.1848 MG/DL THE UOM SHOULD BE CONFIGURED ON THE ANALYZER TO BE UG/ML OR MG/L, NOT MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION A1 PATIENT IDENTIFIER SIDS: (B)(6).