IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2025-00207 ON 14-NOV-2025. ADDITIONAL INFORMATION 18-DEC-2025: UPON REVIEWING THE BACKUP FILES FOR THE INSTRUMENT, IT WAS OBSERVED THAT NEAR THE TIME OF THE ERRONEOUS RESULT FOR THE F2 ALLERGEN, THERE WAS A SEQUENCE OF "NOT DETECTED" RESULTS FOR OTHER SAMPLES. ADDITIONALLY, ON THE EVENT DATE (19-OCT-2025) SEVERAL INSTRUMENT ERROR FLAGS WERE OBSERVED RELATED TO SUBSTRATE AND LUMINOMETER TEMPERATURE ("SUBSTRATE TEMPERATURE LOW" AND "LUMINOMETER TEMPERATURE LOW"). THE INSTRUMENT UNDERWENT TECHNICAL SERVICE ON THE SAME DAY. A FAILURE WITH THE GENEVA HOME SENSOR WAS OBSERVED DURING SERVICING. THE INCUBATOR MODULE WAS REMOVED, AND THE SENSOR WAS CLEANED. THE MODULE WAS REINSTALLED AND A FUNCTIONAL TESTING WAS PERFORMED. AFTER THE SERVICE, THE INSTRUMENT WAS OPERATIONAL. THE ORIGINAL SAMPLE AND THE SEQUENTIAL SAMPLE USED FOR THE REPETITIONS ARE NO LONGER AVAILABLE FOR VISUAL INSPECTION OR FURTHER TESTING. GIVEN THE ABOVE, IT IS NOT POSSIBLE TO RULE OUT PRE-ANALYTICAL FACTORS AS THE ROOT CAUSE OF THE RESULT DISCREPANCY. IT IS ALSO NOT POSSIBLE TO RULE OUT INSTRUMENT-RELATED CAUSES AS A CONTRIBUTING FACTOR TO THE DISCREPANCY. THE COMPLAINT WAS RESOLVED BY ROUTINE TROUBLESHOOTING. THE INSTRUMENT IS OPERATIONAL FOLLOWING NORMAL SERVICE ACTIVITIES. THE IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT LOT 168 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 CONCLUSIONS CODES WERE UPDATED.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY DEPRESSED F2 (MILK) ALLERGEN RESULT OBTAINED ON A PATIENT SAMPLE USING 3GALLERGY SPECIFIC IGE UNIVERSAL KIT ON AN IMMULITE 2000 XPI INSTRUMENT. QUALITY CONTROLS (QCS) RECOVERED WITHIN RANGES ON THE DAY OF THE EVENT. THE INSTRUMENT LOGS FOR THE ANALYZER (IMMULITE 2000 XPI SERIAL NUMBER #(B)(6)) WERE REVIEWED AND IT WAS OBSERVED THAT, NEAR THE TIME OF THE FIRST RESULT, THERE WAS A SEQUENCE OF "NOT DETECTED" RESULTS. IN ADDITION, ON OCTOBER 19, 2025, SEVERAL ERRORS RELATED TO SUBSTRATE AND LUMINOMETER TEMPERATURE ("SUBSTRATE TEMPERATURE LOW" AND "LUMINOMETER TEMPERATURE LOW") WERE RECORDED AFTER 06:00:00. THE EQUIPMENT UNDERWENT TECHNICAL SERVICE ON THE SAME DAY, WITH THE FOLLOWING ACTIONS PERFORMED: "ROOT CAUSE DIAGNOSIS: FAILURE IN THE GENEVA HOME SENSOR. REMOVAL OF THE INCUBATOR MODULE AND CLEANING OF THE SENSOR. REINSTALLATION OF THE MODULE AND FUNCTIONAL TEST. AFTER THE PROCEDURES, THE EQUIPMENT WAS CONSIDERED 100% OPERATIONAL." THE ORIGINAL SAMPLE AND THE SEQUENTIAL SAMPLE USED FOR THE REPETITIONS ARE NO LONGER AVAILABLE FOR VISUAL INSPECTION OR FURTHER TESTING. THE LIMITATIONS SECTION OF THE IMMULITE 2000 3GALLERGY¿ SPECIFIC IGE UNIVERSAL KIT INSTRUCTIONS FOR USE (IFU) 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. NOTE: THIS OUS PRODUCT (CATALOG NUMBER 10380875, AS LISTED IN D4) IS ASSOCIATED WITH SIMILAR PRODUCT IN THE UNITED STATES: CATALOG NUMBER 10708840 / PREMARKET APPROVAL (PMA)# K101572.

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED F2 (MILK) ALLERGEN RESULT OBTAINED ON A PATIENT SAMPLE USING 3GALLERGY SPECIFIC IGE UNIVERSAL KIT ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE PATIENT WAS REPEATED FROM ANOTHER SAMPLE ON THE SAME INSTRUMENT AND AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT FROM THE SAME INSTRUMENT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED ALLERGEN RESULT.