IMMULITE 2000 ANDROSTENEDIONE

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF DISCORDANT ELEVATED ANDROSTENEDIONE PATIENT RESULTS WHEN USING KIT LOT 509 ON AN IMMULITE 2000 XPI INSTRUMENT. THE ADJUSTMENT WAS VALID AND QUALITY CONTROL WAS WITHIN RANGE ON THE DATE OF TESTING. NO EVENTS RECORDED IN THE SYSTEM LOGS WERE FOUND THAT WOULD EXPLAIN THE OBSERVED DISCORDANT RESULTS. THE LIMITATIONS SECTION FOR THE IMMULITE 2000 ANDROSTENEDIONE INSTRUCTIONS FOR USE STATES "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT ELEVATED ANDROSTENEDIONE PATIENT RESULTS WHEN USING KIT LOT 509 ON AN IMMULITE 2000 XPI INSTRUMENT. THE RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT AND THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

Additional Manufacturer Narrative

SIEMENS FILED INITIAL MDR 1219913-2026-00041 ON 17-FEB-2026. ADDITIONAL INFORMATION: 23-MAR-2026. SIEMENS EVALUATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: SIEMENS HEALTHINEERS REVIEWED THE COMPLAINT FOR DISCORDANT ANDROSTENEDIONE RESULTS WHEN USING LOT 509 ON AN IMMULITE 2000 XPI INSTRUMENT. SYSTEM FILES, INCLUDING REAGENT LEVEL SENSE DATA, WERE REVIEWED FOR THE TIME PERIOD THE DISCORDANT RESULTS WERE GENERATED. THE ENCODER VALUES DID NOT REVEAL ANY OCCURRENCES OF FOAM OR BUBBLES ON THE REAGENT AND QUALITY CONTROL WAS IN RANGE AT THE TIME OF TESTING. THE ERROR LOG WAS REVIEWED FOR THIS SAME TIMEFRAME AND AN INCREASE IN THE FREQUENCY OF ERROR 237, 'SAMPLE PIPETTOR DID NOT LEVEL SENSE', AND ERROR 633 'CLEAN DILUTION WELL FAIL-SAFE TRIGGERED', WERE OBSERVED. THESE ERRORS CANNOT BE RULED OUT AS CONTRIBUTING TO THE DISCORDANT RESULTS. IN ADDITION, WHILE SIX WEDGES OF ANDROSTENEDIONE REAGENT WERE ON THE SYSTEM, ONLY ONE WEDGE WAS USED FOR THE DISCORDANT PATIENT RESULTS. AN INSTABILITY OR CONTAMINATION OF THIS ANDROSTENEDIONE REAGENT WEDGE CANNOT BE RULED OUT. THE CUSTOMER IS OPERATIONAL PERFORMING ANDROSTENEDIONE TESTING AFTER THE REAGENT WAS REPLACED AND CALIBRATED. IMMULITE 2000 XPI ANDROSTENEDIONE LOT 509 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES WERE UPDATED.