THYROXINE

Description of Event or Problem

THE USER RECEIVED QUESTIONABLE T4 RESULTS FROM THE COBAS E411 RACK ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULT FOR ONE PATIENT SAMPLE WAS DISCREPANT. THE INITIAL RESULT WAS >24.9 UG/DL. THE SAMPLE WAS REPEATED ON (B)(6) 2011 AND THE REPEAT RESULT WAS >24.9 UG/DL. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2011 AND THE RESULT WAS 7.33 UG/DL. THE USER CALLED THE DOCTOR'S OFFICE THE MORNING AFTER THE >24.9 UG/DL WAS ORIGINALLY REPORTED AND TOLD THEM TO DISREGARD THAT VALUE. THE RESULT OF 7.33 UG/DL WAS THE FINAL, CORRECTED RESULT REPORTED ON (B)(6) 2011. THE USER DID NOT THINK THE PATIENT WAS AFFECTED BUT HAD NO ACCESS TO FIND OUT IF ANY TREATMENT WAS GIVEN OR WITHHELD DUE TO THE ERRONEOUS RESULT. THE USER STATED SHE HAD NOT HEARD OF ANY AFFECT TO ANY PATIENTS. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE SYRINGE WAS LEAKING AND HE ADJUSTED IT. HE REPLACED THE MEASURING CELL AS A PRECAUTIONARY MEASURE. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING, CALIBRATION AND QUALITY CONTROL WITH PASSING RESULTS.

Additional Manufacturer Narrative

OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORTS WITH PATIENT IDENTIFIERS: (B)(6).