ARCHITECT TSH

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT TSH (THYROID STIMULATING HORMONE) RESULT FOR A 27-YEAR-OLD FEMALE PATIENT UNDERGOING A PHYSICAL EXAMINATION TO PREPARE FOR PREGNANCY. THE FOLLOWING DATA WAS PROVIDED: INITIAL TSH RESULT = 7.819 MIU/L. REPEAT TSH RESULT = 3.132 MIU/L. CUSTOMER¿S REFERENCE RANGE IS 0.35 TO 4.94 MIU/L. THE CLINICAL PHYSICIAN QUESTIONED THE INITIAL RESULT AND DID NOT BELIEVE THE RESULTS COULD DIFFER THAT MUCH OVER TWO DAYS. THE CUSTOMER RETESTED THE TWO SAMPLES, AND THE RESULTS WERE CONSISTENT. QUALITY CONTROL WAS WITHIN RANGE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K62-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K62, WITH 510K/PMA/BLA NUMBER K983442. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.