IMMULITE 2000 XPI THYROGLOBULIN (TG)

Additional Manufacturer Narrative

AN OUTSIDE THE CUSTOMER HAS OBSERVED FAILED QC FAILURES AND/OR KIT ADJUSTMENT INTERCEPT VALUES NOT MEETING GUIDELINES ON THE IMMULITE 2000 SYSTEM WHEN USING KIT LOT 432. PATIENT SAMPLES RESULTS WERE NOT GENERATED OR REPORTED. 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 12/8/2022, AND AN URGENT FIELD SAFETY NOTICE (UFSN, LETTER IMC23-04.A.OUS) WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS ON 12/7/2022. 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.

Description of Event or Problem

CUSTOMER INDICATED FAILED QC FAILURES AND/OR KIT ADJUSTMENT INTERCEPT VALUES NOT MEETING GUIDELINES ON THE IMMULITE 2000 SYSTEM WHEN USING KIT LOT 432. PATIENT SAMPLES RESULTS WERE NOT GENERATED OR REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED QUALITY CONTROL SAMPLES.