T4

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE THYROXINE (T4) RESULTS AND PROVIDED DATA FOR EIGHT PATIENT SAMPLES FROM COBAS E601, SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR THREE PATIENT SAMPLES WERE DISCREPANT. THE CUSTOMER HAD LOADED A STANDBY PACK OF REAGENT AND PERFORMED CALIBRATION. THE CONTROLS FOLLOWING THE CALIBRATION FAILED. THEY REPEATED THE CONTROLS BUT ONLY FOR THE CURRENT PACK OF REAGENT IN USE AND NOT THE STANDBY PACK. THEY CONTINUED TO RUN AND REPORT PATIENT RESULTS WITHOUT REPEATING CONTROLS ON THE STANDBY PACK OF REAGENT. REPEAT TESTING WAS PERFORMED ON (B)(6) 2012 ON COBAS E601, SERIAL NUMBER (B)(4). ALL RESULTS ARE IN UG/DL. PATIENT SAMPLE (B)(6) INITIAL RESULT WAS 11.86, REPEAT RESULT WAS 7.50. PATIENT SAMPLE (B)(6) INITIAL RESULT WAS 11.90, REPEAT RESULT WAS 7.21. PATIENT SAMPLE (B)(6) INITIAL RESULT WAS 11.61, REPEAT RESULT WAS 7.06. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS CONTAMINATION. THE CUSTOMER REPLACED THE CONTAMINATED STANDBY REAGENT PACK AND RECALIBRATED USING ANOTHER PACK OF T4 REAGENT. CALIBRATION AND QC WERE ACCEPTABLE TO THE CUSTOMER. THE FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE TESTING WITH ALL RESULTS IN SPECIFICATION.

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THE MOST LIKELY REASON FOR THE FALSE HIGH RESULTS WAS A CALIBRATION ISSUE OR A CALIBRATOR HANDLING ISSUE. IT WAS NOTED THE SIGNAL OF CALIBRATOR 1 WAS SIGNIFICANTLY ELEVATED AND THE CONTROLS WERE FOUND OUT OF RANGE ON (B)(4) 2012 AND (B)(4) 2012. FURTHER CLARIFICATION WAS NOT POSSIBLE BECAUSE THE CUSTOMER COULD NOT VERIFY THAT THE CORRECT CALIBRATORS WERE USED OR THE CONDITION OF THE CALIBRATORS.

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.