ACCESS® FREE T4 CALIBRATORS

Description of Event or Problem

THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ERRONEOUSLY LOW RESULTS FOR FREE THYROXINE (FREE T4) FOR (B)(6) SAMPLES ASSAYED WITH ACCESS FREE T4 REAGENT ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. NO PATIENT SAMPLES WERE ASSAYED AND NO PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY THAT ARE ASSOCIATED WITH THIS EVENT. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER REPORTED THAT THE FREE T4 RESULTS FOR FOUR (4) (B)(4) SURVEY SAMPLES HAD FAILED ON THE LOW END OF ACCEPTABLE RANGES. IT WAS DETERMINED THAT THE CUSTOMER WAS NOT AWARE OF THE PROPER STORAGE CONDITIONS OF THE LOT NUMBER OF FREE T4 CALIBRATORS BEING USED (LOT #017458). THE STORAGE CONDITIONS FOR THIS LOT OF CALIBRATORS WAS VALIDATED FOR ONE-TIME USE AND REQUIRES FROZEN STORAGE AT -20 DEGREES CELSIUS. SUBSEQUENT LOTS OF FREE T4 CALIBRATORS (I.E., LOT NUMBERS GREATER THAN 017458) ARE STORED FROZEN AT -20 DEGREES CELSIUS AND MAY BE THAWED/FROZEN UP TO A MAXIMUM OF FIVE (5) CYCLES. USE ERROR WAS DETERMINED TO BE THE ROOT CAUSE OF THIS EVENT. AFTER RECALIBRATING THE FREE T4 ASSAY WITH A NEW (NEVER THAWED) BOX OF FREE T4 CALIBRATORS (LOT #109605), ALL FREE T4 RESULTS FOR THE (B)(4) SURVEY SAMPLES RECOVERED WITHIN ACCEPTABLE RANGES.

Additional Manufacturer Narrative

A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE.THE CUSTOMER REPORTED THAT A SYSTEM CHECK PERFORMED ON THE ANALYZER ON (B)(4) 2011 MET PERFORMANCE SPECIFICATIONS.THE CUSTOMER REPORTED THAT QUALITY CONTROL (QC) RESULTS FOR FREE T4 WERE RECOVERING LOW OUTSIDE THE LABORATORY'S ESTABLISHED RANGES AT THE TIME OF THE EVENT.THE CUSTOMER REPORTED THAT NO OTHER ASSAYS WERE IMPACTED BY THIS EVENT.