ELECSYS T4 ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). (B)(4).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS T4 ASSAY (T4) ON A COBAS E 411 IMMUNOASSAY ANALYZER (E411). THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED WITH A T4 VALUE OF 18 UG/ML WHEN TESTED ON THE CUSTOMER'S E411 ANALYZER. THE SAMPLE WAS TESTED ON A VIDAS ANALYZER AND THE T4 RESULT WAS 9 UG/ML. THE SAMPLE WAS ALSO TESTED ON A SECOND E411 ANALYZER IN A DIFFERENT LABORATORY, RESULTING WITH A T4 VALUE OF 20 UG/ML. A FRESH SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED. THE VALUES FROM THIS SAMPLE WERE THE SAME AS PREVIOUS VALUES. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBERS OF THE E411 ANALYZERS USED AT THE CUSTOMER SITE AND OTHER LABORATORY WERE ASKED FOR, BUT NOT PROVIDED. THE CUSTOMER DOES NOT USE QUALITY CONTROL MATERIAL. DURING TROUBLESHOOTING, QUALITY CONTROL MATERIAL WAS TESTED ON THE CUSTOMER'S E411 ANALYZER AND RECOVERED WITHIN LIMITS. CALIBRATION SIGNALS WERE WITHIN RANGE ON THE CUSTOMER'S E411 ANALYZER. NO ISSUES WERE FOUND WITH THE CUSTOMER'S E411 ANALYZER. CALIBRATION AND QUALITY CONTROL RECOVERIES AT THE OTHER LABORATORY WERE WITHIN LIMITS.

Additional Manufacturer Narrative

THE CORRECT UNIT OF MEASURE USED FOR T4 WAS CONFIRMED TO BE UG/DL. NO REGULAR CONTROL VALUES ARE MEASURED AT THE CUSTOMER SITE AND THIS DOES NOT FOLLOW GOOD LABORATORY PRACTICES. ACCORDING TO PRODUCT LABELING, CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION. BASED ON THE INFORMATION PROVIDED A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. THE CUSTOMER ACCEPTS THE T4 VALUE GENERATED WITH THE ROCHE ANALYZERS AND THIS VALUE WAS CONFIRMED IN ANOTHER LABORATORY ON A SECOND SAMPLE COLLECTED FROM THE PATIENT.