IMMULITE 2000 XPI THYROGLOBULIN (TG)

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER HAS OBSERVED FAILED QC AND IMPRECISION ON THE IMMULITE 2000 XPI SYSTEM WHEN USING THYROGLOBULIN (TG) KIT LOT 435. THERE IS NO REPORT THAT ERRONEOUS PATIENT SAMPLE RESULTS WERE GENERATED OR REPORTED. CUSTOMER INDICATED THAT THERE WAS A DELAY DUE TO FAILED QC/IMPRECISION IN QC EXCEEDING GUIDELINES. 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 AND IMPRECISION ON THE IMMULITE 2000 XPI SYSTEM WHEN USING THYROGLOBULIN (TG) KIT LOT 435. THERE IS NO REPORT THAT ERRONEOUS PATIENT SAMPLE RESULTS WERE GENERATED OR REPORTED. CUSTOMER INDICATED THAT THERE WAS A DELAY DUE TO FAILED QC/IMPRECISION IN QC EXCEEDING GUIDELINES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED QUALITY CONTROL SAMPLES.