ELECSYS T4 ASSAY

Additional Manufacturer Narrative

(B)(4). (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS TSH ASSAY (TSH), ELECSYS T4 ASSAY (T4), ELECSYS T3 (T3), ELECSYS FT3 III (FT3 III), AND ELECSYS FT4 II ASSAY (FT4 II). THE PATIENT SAMPLES WERE TESTED ON A COBAS 8000 E 801 MODULE, COBAS 8000 E 602, COBAS 8000 E 601, ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER, AND A SIEMENS CENTAURO. OF THE DATA PROVIDED FOR 3 PATIENTS, 1 PATIENT HAD REPORTABLE MALFUNCTIONS FOR TSH, T4, AND T3, 1 PATIENT HAD REPORTABLE MALFUNCTIONS FOR TSH, T4, T3, AND FT4 II, AND 1 PATIENT HAD A REPORTABLE MALFUNCTION FOR T4. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. MEDWATCHES FOR THIS EVENT INCLUDE THOSE WITH (B)(6). THE INVESTIGATION IS CURRENTLY ONGOING.

Additional Manufacturer Narrative

A NEW BLOOD DRAW WAS PERFORMED FOR ALL 3 PATIENT SAMPLES AND TESTED ON (B)(6) 2018. PLEASE REFER TO THE ATTACHMENT TO THIS MEDWATCH FOR NEW RELEVANT DATA. DISCREPANT RESULTS ARE HIGHLIGHTED. FOR PATIENT 1 AND PATIENT 2, THERE IS NOW ALSO A REPORTABLE MALFUNCTION FOR FT3 III. FOR PATIENT 3 THERE IS NOW ALSO A REPORTABLE MALFUNCTION FOR TSH. MEDWATCH FOR THE FT3 III HAS THE PATIENT IDENTIFIER OF (B)(6). PATIENT 2 IS A (B)(6) YEAR OLD FEMALE WITH A DATE OF BIRTH THAT WAS NOT PROVIDED. PATIENT 3 IS A (B)(6) YEAR OLD FEMALE WITH A DATE OF BIRTH THAT WAS NOT PROVIDED. PATIENT 3 IS TAKING RISPERIDONE. THE CUSTOMER'S COBAS E801 SERIAL NUMBER WAS (B)(4). FURTHER INVESTIGATION SHOWED THAT THE CUSTOMER WAS NOT USING RACK UPDATERS. CALIBRATION AND QC DATA WAS ACCEPTABLE. THE INVESTIGATION IS CURRENTLY ONGOING.

Additional Manufacturer Narrative

THE CUSTOMER SENT IN 5 PATIENT SAMPLES TO BE INVESTIGATED. THE DATA FOR TWO OF THE PATIENTS (PATIENT 4 AND PATIENT 5) HAD NOT BEEN PREVIOUSLY PROVIDED. PLEASE REFER TO THE ATTACHMENT TO THIS MEDWATCH FOR RELEVANT DATA IN RELATION TO PATIENT 4 AND PATIENT 5. DISCREPANT RESULTS ARE HIGHLIGHTED. FOR BOTH PATIENT 4 AND PATIENT 5 THE ERRONEOUS RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE INVESTIGATION IS CURRENTLY ONGOING. (B)(4).

Additional Manufacturer Narrative

SAMPLES FOR 5 SEPARATE PATIENTS WERE SUBMITTED FOR FURTHER INVESTIGATION. FOR PATIENT 1 AN INTERFERING FACTOR WAS FOUND IN THE SAMPLE. THE INTERFERING FACTOR MOST LIKELY CAUSED THE FALSELY INCREASED VALUES OF THE FT3III AND T4 AND T3 ASSAYS ON THE COBAS E 801 MODULE. THE DIFFERENT VALUES OF THE FT3III AND T4 AND T3 ASSAYS, GENERATED WITH THE DIFFERENT ANALYZERS FROM ROCHE DIAGNOSTICS, MOST LIKELY RELATE TO THE PHYSICAL REACTION CONDITIONS OF THESE ASSAYS ON THE DIFFERENT TYPES OF ANALYZERS. TO THE MATHEMATICAL DIFFERENCE OF THE TSH VALUES GENERATED WITH THE ANALYZERS FROM ROCHE DIAGNOSTICS AND SIEMENS, IT NEEDS TO BE TAKEN INTO ACCOUNT THAT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN REFERENCE MATERIALS AND THE STANDARDIZATION METHODOLOGY USED. FOR PATIENT 2 AN INTERFERING FACTOR WAS FOUND IN THE SAMPLE.THE INTERFERING FACTOR MOST LIKELY CAUSED THE FALSELY ELEVATED VALUES OF THE FT3III AND T4 AND T3 ASSAYS ON THE COBAS E 801 MODULE. THE DIFFERENT VALUES OF THE FT4II, FT3III AND T4 AND T3 ASSAYS, GENERATED WITH THE DIFFERENT ANALYZERS FROM ROCHE DIAGNOSTICS, MOST LIKELY RELATE TO THE PHYSICAL REACTION CONDITIONS OF THESE ASSAYS ON THE DIFFERENT TYPES OF ANALYZERS. TO THE MATHEMATICAL DIFFERENCE OF THE TSH AND FT4II VALUES GENERATED WITH THE ANALYZERS FROM ROCHE DIAGNOSTICS AND SIEMENS, IT NEEDS TO BE TAKEN INTO ACCOUNT THAT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN REFERENCE MATERIALS AND THE STANDARDIZATION METHODOLOGY USED. FOR PATIENT 3 AN INTERFERING FACTOR WAS FOUND IN THE SAMPLE. THE INTERFERING FACTOR MOST LIKELY CAUSED THE FALSELY ELEVATED VALUES OF THE T4 AND T3 ASSAYS ON THE COBAS E 801 MODULE. THE DIFFERENT VALUES OF THE T4 AND T3 ASSAYS, GENERATED WITH THE DIFFERENT ANALYZERS FROM ROCHE DIAGNOSTICS, MOST LIKELY RELATE TO THE PHYSICAL REACTION CONDITIONS OF THE ASSAYS ON THE DIFFERENT TYPES OF ANALYZERS. TO THE MATHEMATICAL DIFFERENCE OF THE TSH VALUES GENERATED WITH THE ANALYZERS FROM ROCHE DIAGNOSTICS AND SIEMENS, IT NEEDS TO BE TAKEN INTO ACCOUNT THAT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN REFERENCE MATERIALS AND THE STANDARDIZATION METHODOLOGY USED. FOR PATIENT 4 NO INTERFERING FACTOR WAS FOUND. TO THE MATHEMATICAL DIFFERENCE OF THE TSH, T4, AND T3 VALUES GENERATED WITH THE ANALYZERS FROM ROCHE DIAGNOSTICS AND SIEMENS, IT NEEDS TO BE TAKEN INTO ACCOUNT THAT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN REFERENCE MATERIALS AND THE STANDARDIZATION METHODOLOGY USED. FOR PATIENT 5 AN INTERFERING FACTOR WAS FOUND IN THE SAMPLE. THE T4 AND T3 ELEVATED RESULTS WERE LIKELY CAUSED BY THE INTERFERENCE. THE DIFFERENT VALUES GENERATED FOR FT4II, T4, AND T3 BETWEEN DIFFERENT ANALYZERS FROM ROCHE DIAGNOSTICS, IS MOST LIKELY RELATED TO THE PHYSICAL REACTION CONDITIONS OF THESE ASSAYS ON THE DIFFERENT TYPES OF ANALYZERS. FOR WHEN AN INTERFERENT AGAINST A COMPONENT OF THE REAGENT WAS CONFIRMED, THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING. PRODUCT LABELING STATES "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."