IMMULITE 2000 XPI THYROGLOBULIN

Description of Event or Problem

THE CUSTOMER INDICATED POOR ADJUSTMENT AND QUALITY CONTROL RESULTS OUTSIDE OF SPECIFICATIONS WHEN USING IMMULITE XPI 2000 SYSTEMS WHEN USING THYROGLOBULIN KIT LOT 434. THE CUSTOMER STARTED USING A BIO-RAD QUALITY CONTROLS, WHICH RESULTED IN RANGE, AND THUS CONTINUED TO REPORT PATIENT DATA. THERE WERE NO DISCORDANT PATIENT RESULTS PROVIDED BY THE CUSTOMER. THE CUSTOMER INDICATED THERE WAS NO IMPACT TO PATIENT TESTING, AND THEY CONTINUED TO PROCESS PATIENT SAMPLES FOR THYROGLOBULIN WITH KIT LOT 434. IT IS UNKNOWN IF THE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED QUALITY CONTROL SAMPLES.

Additional Manufacturer Narrative

AN OUTSIDE OF THE US CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT POOR ADJUSTMENT AND QUALITY CONTROL RESULTS OUTSIDE OF SPECIFICATIONS WHEN USING IMMULITE XPI 2000 SYSTEMS WHEN USING THYROGLOBULIN KIT LOT 434. 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.