IMMULITE 2000 THYROGLOBULIN

Description of Event or Problem

THE CUSTOMER REPORTED AN IMPRECISION ON THYROGLOBULIN QUALITY CONTROL (LOT 432) ON AN IMMULITE 2000 INSTRUMENT. DUE TO THE QUALITY CONTROL (QC) ISSUE THE CUSTOMER HAS STOPPED PROCESSING THYROGLOBULIN PATIENT RESULTS. THERE WERE NO PATIENT RESULTS GENERATED OR REPORTED AT THE TIME. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT FAILED QUALITY CONTROL SAMPLES ON THE IMMULITE 2000 WHEN USING THYROGLOBULIN KIT LOT 431. THERE WAS NO PATIENT DATA PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED QUALITY CONTROL SAMPLES. 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.