IMMULITE 2000 XPI THYROGLOBULIN

Description of Event or Problem

THE CUSTOMER OBSERVED A HIGHER ADJUSTMENT INTERCEPT OVER TIME. IN ADDITION, RECENT ADJUSTMENTS SHOWED THAT THE LOW ADJUSTMENT COUNTS PER SECOND (CPS) WAS THREE TIMES HIGHER THAN THE EXPECTED VALUE. DISCORDANT PATIENT RESULTS WERE NOT PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH CPS OF THE LOW ADJUSTER.

Additional Manufacturer Narrative

AN OUTSIDE OF US (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT HIGH CPS OF THE LOW ADJUSTER VERSUS THE TARGET COUNTS PER SECOND (CPS) WHEN USING IMMULTE 2000 THYROGLOBULIN KIT LOT 433 ON THE IMMULITE 2000 XPI SYSTEM. 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.