IMMULITE 2000 IGF-I

Additional Manufacturer Narrative

A CUSTOMER LOCATED OUTSIDE THE UNITED STATES CONTACTED SIEMENS DIAGNOSTIC REMOTE SERVICE CENTER REGARDING THE OBSERVATION OF IMMULITE 2000 XPI (SERIAL NUMBER: (B)(6), IMMULITE 2000 IGF-1 (SMN 11128543), LOT: (357) GENERATED INITIAL DISCREPANCIES. SAMPLE PROCESSING WAS REPEATED ON A DIFFERENT ANALYZER (SERIAL NUMBER: (B)(6) AND CONSIDERED CORRECT. QUALITY CONTROL MATERIAL WAS IN RANGE. THE ADJUSTMENT IN USE AT THE TIME THE SAMPLES WERE PROCESSED WAS PERFORMED ON (B)(6) 2026 AND DEMONSTRATED ACCEPTABLE PERFORMANCE CONSISTENT WITH THE ANALYZER'S HISTORICAL TREND. THE CUSTOMER RECEIVES SAMPLES FROZEN AT -20°C AND, PRIOR TO ANALYSIS, PERFORMS A THAWING STEP FOLLOWED BY CENTRIFUGATION BEFORE PROCESSING ON THE ANALYZER. AFTER TESTING, SAMPLES ARE REFROZEN TO ALLOW FOR FUTURE REPEAT TESTING IF NECESSARY. DURING THE INVESTIGATION, THE LOCAL SUPPORT TEAM REVIEWED THE ANALYZER EVENT LOGS AND DID NOT IDENTIFY ANY MESSAGES OR ALERTS SUGGESTIVE OF MECHANICAL ISSUES THAT COULD EXPLAIN THE OBSERVED DISCREPANCIES. ADDITIONALLY, THE CUSTOMER DID NOT REPORT SIMILAR OCCURRENCES WITH OTHER ASSAYS PROCESSED ON THE SAME ANALYZER. SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED IGF-I (INSULIN-LIKE GROWTH FACTOR I) RESULTS OBTAINED ON FOUR (4) PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEATED RESULTS WERE CONSIDERED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED IGF-I RESULTS.