T4

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). PATIENT WAS BORN IN 1950. (B)(4).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF ERRONEOUS HIGH "S-TRAK" RESULTS FOR 3 PATIENT SAMPLES WHEN COMPARED BETWEEN THE COBAS SYSTEM AND A BRAHMS KRYPTOR COMPACT SYSTEM. THE "S-TRAK" RESULTS ARE BELIEVED TO BE RESULTS FOR ANTIBODIES TO TSH RECEPTOR (ANTI-TSHR). THE VALUES WERE NORMAL FOR ALL 3 PATIENTS ON THE BRAHMS KRYPTOR COMPACT SYSTEM WHICH MATCHED THE CLINICAL PICTURE FOR EACH PATIENT. THE CUSTOMER NOTED THAT, FOR THESE 3 PATIENTS, OTHER THYROID TESTS ALSO RAN HIGHER ON THE COBAS SYSTEM WHEN COMPARED TO OTHER ANALYZERS. BASED ON THE DATA PROVIDED ERRONEOUS THYROTROPIN (TSH), FREE THYROXINE (FT4), THYROXINE (T4), FREE TRIIODOTHYRONINE (FT3), AND TRIIODOTHYRONINE (T3) WERE IDENTIFIED. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS INFORMATION WAS REQUESTED. THE DATE OF EVENT FOR EACH PATIENT IS NOT KNOWN. PLEASE SEE THE ATTACHMENT TO THE MEDWATCH FOR TEST RESULTS AND PATIENT DEMOGRAPHICS. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TSHR ERRONEOUS RESULTS. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH ERRONEOUS RESULTS. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 ERRONEOUS RESULTS. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 ERRONEOUS RESULTS. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 ERRONEOUS RESULTS. NO ADVERSE EVENTS REPORTED. THE COBAS E602 ANALYZER SERIAL NUMBER WAS NOT PROVIDED.

Additional Manufacturer Narrative

THE 3 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE PRESENCE OF A STREPTAVIDIN INTERFERING FACTOR. THIS SPECIFIC INTERFERENCE IS ADDRESSED IN PRODUCT LABELING.

Additional Manufacturer Narrative

CLARIFICATION WAS RECEIVED THAT THE "S-TRAK" RESULTS ARE RESULTS FOR ANTIBODIES TO TSH RECEPTOR (ANTI-TSHR). THE RESULTS FOR EACH PATIENT WERE OBTAINED FROM THE SAME SAMPLE. CLARIFICATION WAS RECEIVED THAT THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIANS DID NOT AGREE WITH THE RESULTS. CLARIFICATION WAS RECEIVED THAT NONE OF THE PATIENTS WERE ADVERSELY AFFECTED.