IMMULITE 2000 THYROGLOBULIN

Additional Manufacturer Narrative

A US CUSTOMER CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT IMPRECISION ON LEVEL 1 (LOWER CONCENTRATION) QUALITY CONTROL SAMPLES AND OCCASION FAILED LEVEL 1 QUALITY CONTROL SAMPLES OUTSIDE OF SPECIFICATIONS ON THE IMMULITE 2000 SYSTEMS WHEN USING THYROGLOBULIN KIT LOT D434. 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

THE CUSTOMER INDICATED IMPRECISION ON LEVEL 1 (LOWER CONCENTRATION) QUALITY CONTROL SAMPLES AND OCCASION FAILED LEVEL 1 QUALITY CONTROL SAMPLES OUTSIDE OF SPECIFICATIONS ON THE IMMULITE 2000 SYSTEMS WHEN USING THYROGLOBULIN KIT LOT D434. WHEN QUALITY CONTROL RECOVERED OUTSIDE OF RANGE, PATIENT RESULTS WERE NOT GENERATED OR REPORTED. IN ALL CASES FOR QUALITY CONTROL OUTSIDE OF RANGE, ACCEPTABLE RESULTS WERE RECOVERED AFTER ASSAY ADJUSTMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED QUALITY CONTROL SAMPLES.