TINA-QUANT FERRITIN GEN.4

Additional Manufacturer Narrative

THERE WAS NOT ENOUGH SAMPLE VOLUME LEFT FOR FURTHER INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

PROTEIN ELECTROPHORESIS WAS RUN ON THE SAMPLE FROM (B)(6) 2021. RESULTS FROM THE ELECTROPHORESIS DETERMINED THERE WAS "ARGUABLE POLYCLONAL IGA AUGMENTATION". THIS POLYCLONAL ANTIBODY MAY POTENTIALLY CAUSE NON-SPECIFIC AGGLUTINATION AND TURBIDITY IN THE ASSAY, WHICH MAY POTENTIALLY CAUSE THE DISCREPANT RESULTS. AUTOANTIBODIES DUE TO THE PATIENT'S AUTOIMMUNE DISEASE ("PRESENCE OF ANTI SSA RO 60") MAY INTERFERE WITH THE TEST. INVESTIGATIONS ARE STILL ONGOING.

Additional Manufacturer Narrative

ON (B)(6) 2021, THE PATIENT CAME BACK TO THE LABORATORY AND HAD ANOTHER SAMPLE COLLECTED. THE CUSTOMER PROVIDED THE PATIENT'S SAMPLES COLLECTED ON (B)(6) 2021 AND (B)(6) 2021 FOR INVESTIGATION. BOTH SAMPLES WERE MEASURED ON A COBAS PURE C503 ANALYZER AND AN E 801 MODULE. THE ASSAYS TESTED WERE FERRITIN, IGA, IGG, AND IGM BELOW ARE THE INVESTIGATION'S FERRITIN RESULTS FOR THE 04-MAR-2021 SAMPLE: FERRITIN ON THE E 801 MODULE: 13.7 G/L. FERRITIN ON THE E 801 MODULE WITH 1:5 DILUTION: 12.5 G/L. FERRITIN ON THE C503 ANALYZER: 235 G/L. FERRITIN ON THE C503 ANALYZER WITH A 1:5 DILUTION: 165 G/L. BELOW ARE THE INVESTIGATION'S FERRITIN RESULTS FOR THE (B)(6) 2021 SAMPLE: FERRITIN ON THE E 801 MODULE: 268 G/L. FERRITIN ON THE E 801 MODULE WITH 1:5 DILUTION: 264 G/L. FERRITIN ON THE C503 ANALYZER: 371 G/L. FERRITIN ON THE C503 ANALYZER WITH A 1:5 DILUTION: 495 G/L. THE INVESTIGATION DETERMINED ALL OF THE IMMUNOGLOBULIN RESULTS WERE WITHIN THE NORMAL RANGE. THE INVESTIGATION CONFIRMED THE CUSTOMER'S DISCREPANT FERRITIN RESULTS WITH THE (B)(6) 2021 SAMPLE BETWEEN THE ELECSYS AND CLINICAL CHEMISTRY METHOD. FURTHERMORE, THE MEASUREMENTS WITH DILUTED SAMPLES SHOWED THE ELECSYS METHOD WAS MORE STABLE THAN THE CLINICAL CHEMISTRY METHOD. AN INTERFERENCE DUE TO IMMUNOGLOBULINS COULD BE EXCLUDED. BASED ON THE CUSTOMER'S PROVIDED CALIBRATION AND QC RESULTS, NO GENERAL PRODUCT PROBLEM WAS FOUND. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

UPDATED MEDWATCH FIELD: B7 OTHER RELEVANT HISTORY.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).. UNIQUE DEVICE IDENTIFIER (UDI) (B)(4). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE FERR4 TINA-QUANT FERRITIN GEN.4 RESULTS FOR ONE PATIENT TESTED ON A COBAS C 503 MODULE AND A COBAS 6000 C (501) MODULE COMPARED TO A COBAS 8000 E 801 MODULE AND AN ABBOTT ANALYZER. THE CUSTOMER CONFIRMED THE CALIBRATION AND QC DATA ON THE COBAS C 503 MODULE WERE ACCEPTABLE PRIOR TO PATIENT TESTING. ON (B)(6) 2021, THE PATIENT'S SAMPLE WAS TESTED ON A COBAS 8000 E 801 MODULE AT A DIFFERENT LABORATORY. THE PATIENT'S FERRITIN RESULT WAS 18 UG/L. ON (B)(6) 2021, THE PATIENT HAD A NEW SAMPLE COLLECTED AND THE SAMPLE WAS TESTED ON AN ABBOTT ANALYZER AT A DIFFERENT LABORATORY. THE PATIENT'S FERRITIN RESULT WAS 12 NG/ML. ON (B)(6) 2021, THE PATIENT HAD A NEW SAMPLE COLLECTED AND THE SAMPLE WAS TESTED ON A COBAS C 503 MODULE AT THE CUSTOMER'S LABORATORY. THE PATIENT'S FERRITIN RESULT WAS 232 NG/ML. THE PATIENT QUESTIONED THE FERRITIN RESULT TESTED ON THE COBAS C 503 MODULE. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE SAME SAMPLE ON A COBAS 6000 C (501) MODULE AND THE PATIENT'S RESULT WAS "AROUND 200 NG/ML." ON (B)(6) 2021, THE SAME SAMPLE FROM (B)(6) 2021 WAS REPEATED ON THE CUSTOMER'S COBAS C 503 MODULE AND THE REPEAT RESULT WAS 219 NG/ML. THE PATIENT WAS PROVIDED TREATMENT BASED ON ABBOTT'S FERRITIN RESULT. THE COBAS C 503 MODULE SERIAL NUMBER WAS (B)(4). THE COBAS 6000 C (501) MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THIS MEDWATCH IS FOR THE FERRITIN ASSAY ON THE COBAS 6000 C (501) MODULE. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER PT-(B)(6) FOR THE FERRITIN ASSAY ON THE COBAS C 503 MODULE.