IMMULITE 2000 XPI THRYOGLOBULIN

Description of Event or Problem

THE CUSTOMER OBSERVED QUALITY CONTROL (QC) IMPRECISION, QC FAILURES, AND ADJUSTMENT INTERCEPT VALUES EXCEEDING LOT GUIDELINE ON AN IMMULITE 2000 XPI SYSTEM WHEN USING THYROGLOBULIN KIT LOT 432. PATIENT SAMPLES (AND SURVEY SAMPLES) WERE TESTED FOR TROUBLESHOOTING PURPOSES ONLY AND WERE NOT INTENDED TO BE REPORTED (SURVEY SAMPLES ARE NOT INCLUDED IN THIS REPORT). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE BIAS OBSERVED.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT FAILED QUALITY CONTROL SAMPLES AND ADJUSTMENT INTERCEPT VALUES EXCEEDING LOT GUIDELINE ON THE IMMULITE 2000 XPI WHEN USING THYROGLOBULIN KIT LOT 432. PATIENT SAMPLES (AND SURVEY SAMPLES) WERE TESTED FOR TROUBLESHOOTING PURPOSES ONLY AND WERE NOT INTENDED TO BE REPORTED (SURVEY SAMPLES ARE NOT INCLUDED IN THIS REPORT). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE BIAS OBSERVED. SIEMENS HEALTHCARE DIAGNOSTICS FURTHER INVESTIGATED THE ISSUE AND HAS CONFIRMED THE POTENTIAL FOR FUNCTIONAL SENSITIVITY TO NOT MEET INSTRUCTIONS FOR USE (IFU) 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 SHOULD NOT BE 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.