ELECSYS FT3 III

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE CUSTOMER¿S ELECSYS FT3 III VALUES COULD BE REPRODUCED. FURTHER INVESTIGATIONS OF THE SAMPLE DETERMINED AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT. PER PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 8000 CORE UNIT WITH SERIAL NUMBER (B)(4), THE INVESTIGATION SITE'S E 411 WITH SERIAL NUMBER (B)(4) AND THE INVESTIGATION SITE'S E 801 WITH SERIAL NUMBER (B)(4). THE REPORTER SENT THE PATIENT SAMPLE TO AN INVESTIGATION SITE FOR RERUNS. THE REPORTER ALSO SENT THE PATIENT SAMPLE TO AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT ANALYZER AND A FUJIREBIO LUMIPULSE ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE REPORTER'S LABORATORY AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 411 IS 611918 WITH AN EXPIRATION DATE OF 30-MAY-2023. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 801 IS 611920 WITH AN EXPIRATION DATE OF 31-MAY-2023.

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. H3 : NA.