ELECSYS ANTI-TPO

Additional Manufacturer Narrative

THE COBAS E 801 MSB/MSBL SERIAL NUMBER IS (B)(6). THE PATIENT'S SAMPLE HAS BEEN RECEIVED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TPO RESULTS FOR 1 PATIENT ON A COBAS E 801 MSB/MSBL MODULE. THE INITIAL RESULT WAS 125 IU/ML (REFERENCE INTERVAL: <34IU/ML), WHICH IS CLINICALLY INTERPRETED AS POSITIVE. THE RESULT ON ANOTHER COBAS E 801 WAS 157 IU/ML, CONFIRMING THE ELEVATED LEVEL AS POSITIVE. THE RESULT USING A SNIBE MAGLUMI X8 ANALYZER WAS 0.061 IU/ML (REFERENCE INTERVAL: <10 IU/ML, WHICH IS CLINICALLY INTERPRETED AS NEGATIVE. THE RESULT USING A SIEMENS ATELLICA IM ANALYZER WAS 28.9 IU/ML (REFERENCE INTERVAL: <60 IU/ML), WHICH IS CLINICALLY INTERPRETED AS NEGATIVE. THE RESULT USING A BECKMAN COULTER UNICEL DXI 800 ANALYZER WAS 1.19 IU/ML (REFERENCE INTERVAL: <9 IU/ML), WHICH IS CLINICALLY INTERPRETED AS NEGATIVE. THE RESULT USING AN ABBOTT ALINITY I / I2000SR ANALZYER WAS 0.33 IU/ML (REFERENCE INTERVAL: <5.61 IU/ML), WHICH IS CLINICALLY INTERPRETED AS NEGATIVE. THE CUSTOMER IS QUESTIONING THE INITIAL RESULTS BASED ON THE CLINICAL PICTURE, NEGATIVE IMAGING, AND UNANIMOUS NEGATIVE RESULTS FROM FOUR OTHER MAJOR MANUFACTURERS. THE PATIENT'S THYROID ULTRASOUND SHOWED NO ABNORMALITIES.