IMMULITE® 2000 THYROGLOBULIN

Description of Event or Problem

THE CUSTOMER OBSERVED A LOW BIAS WITH THE IMMULITE® 2000 THYROGLOBULIN (TG) ASSAY ON QUALITY CONTROL AND PATIENT SAMPLES THAT RAN ON THE IMMULITE 2000 XPI INSTRUMENT. THE CUSTOMER INFORMED SIEMENS THAT THE INITIAL RESULT WAS CORRECT AND REPORTED. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME INSTRUMENT FOR TROUBLESHOOTING PURPOSES. THE CUSTOMER DID NOT REPORT ANY TG PATIENT RESULT WHEN QUALITY CONTROL (QC) INDICATED A LOW BIAS OR WAS OUT OF RANGE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW BIAS OBSERVED WITH THE TG ASSAY.

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS FURTHER INVESTIGATED THE ISSUE AND HAS CONFIRMED THE POTENTIAL FOR FUNCTIONAL SENSITIVITY TO NOT MEET INSTRUCTIONS FOR USE CLAIMS WITH THYROGLOBULIN KIT LOTS D431-D436 (US) AND KIT LOTS 431-436 (OUTSIDE THE US). INVESTIGATION HAS ALSO DEMONSTRATED THAT IMMULITE THYROGLOBULIN CONTROL MODULE CONTROL LEVEL ONE MAY RESULT OUTSIDE OF PUBLISHED RANGES. PER GOOD LABORATORY PRACTICE, PATIENT RESULTS ARE NOT REPORTED WHEN CONTROLS RESULT OUT OF RANGE. WHEN CONTROL RESULTS ARE IN RANGE, USERS MAY OBSERVE INCREASED IMPRECISION WITH LOW LEVEL PATIENT SAMPLES. AN URGENT MEDICAL DEVICE CORRECTION (UMDC, LETTER IMC23-04.A.US) WAS SENT TO US CUSTOMERS (B)(6) 2022, AND AN URGENT FIELD SAFETY NOTICE (UFSN, LETTER IMC23-04.A.OUS) WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS ON (B)(6) 2022. THE UMDC AND UFSN EXPLAIN THE POTENTIAL FOR FUNCTIONAL SENSITIVITY NOT MEETING IFU CLAIMS AND INCREASED IMPRECISION WITH PATIENT SAMPLES WITH LOW LEVEL PATIENT SAMPLES. MDRS 2432235-2022-00372, 2432235-2022-00373, 2432235-2022-00374, 2432235-2022-00375, 2432235-2022-00376, AND 2432235-2022-00377 WERE FILED FOR THE SAME EVENT.