IMMULITE 2000 XPI THYROGLOBULIN

Additional Manufacturer Narrative

A OUTSIDE OF THE US CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT IMPRECISION WITH QUALITY CONTROL SAMPLES WHEN USING IMMULITE 2000 XPI SYSTEMS WHEN USING THYROGLOBULIN KIT LOT 434. IN ADDITION, THE CUSTOMER INDICATED THAT THE LOW ADJUSTOR COUNTS PER SECOND WERE FOUR TIMES HIGHER THAN EXPECTED. 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 (B)(4) ) WAS SENT TO US CUSTOMERS (B)(6) 2022, AND AN URGENT FIELD SAFETY NOTICE (UFSN, LETTER (B)(4) ) 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.

Description of Event or Problem

THE CUSTOMER INDICATED IMPRECISION WITH QUALITY CONTROL SAMPLES WHEN USING IMMULITE 2000 XPI SYSTEMS WHEN USING THYROGLOBULIN KIT LOT 434. IN ADDITION, THE CUSTOMER INDICATED THAT THE LOW ADJUSTOR COUNTS PER SECOND WERE FOUR TIMES HIGHER THAN EXPECTED. IMPRECISION WAS OBSERVED ON PATIENT SAMPLES AND QUALITY CONTROL. THERE WERE NO DISCORDANT PATIENT RESULTS PROVIDED BY THE CUSTOMER. 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.