IMMULITE 2000 XPI THYROGLOBULIN

Description of Event or Problem

THE CUSTOMER INDICATED IMPRECISION ON QUALITY CONTROL LEVEL 1 AND PATIENT SAMPLE RESULTS ON THE IMMULITE 2000 XPI SYSTEM WHEN USING THYROGLOBULIN KIT LOT 433. THE CUSTOMER DID NOT PROVIDE ANY PATIENT SAMPLE DATA AND IT IS UNKNOWN IF THE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE QUALITY CONTROL IMPRECISION.

Additional Manufacturer Narrative

AN OUTSIDE THE US (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT IMRECISION ON QUALITY CONTROL LEVEL 1 AND PATIENT SAMPLE RESULTS ON THE IMMULITE 2000 XPI SYSTEM WHEN USING THYROGLOBULIN KIT LOT 433. 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.