IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2026-00037 ON 12-FEB-2026. ADDITIONAL INFORMATION 03-MAR-2026: SIEMENS HEALTHINEERS REVIEWED THE COMPLAINT INFORMATION AND DATA FILES PROVIDED. THE MAINDATA FILE PROVIDED DID NOT CONTAIN DATA FOR JANUARY 9TH AND JANUARY 10TH AND NO INFORMATION WAS AVAILABLE FOR THE TIME OF THE EVENT. THE ERRORLOG FILE WAS REVIEWED AND THE FOLLOWING ERRORS WERE IDENTIFIED: ERROR 12407 (PROBE WASH EMPTY) AND ERROR 12408 (WATER SUPPLY LOW). IT WAS DETERMINED THAT DURING THE TIMEFRAME WHEN DISCORDANT PATIENT RESULTS WERE OBSERVED, THREE DIFFERENT 3GALLERGY SPECIFIC IGE UNIVERSAL KIT REAGENT WEDGES WERE USED. WITH THE FIRST REAGENT WEDGE, THE QUALITY CONTROL (QC) RESULTS WERE IN RANGE. WITH THE SECOND REAGENT WEDGE, QC FAILURE WAS OBSERVED. THE CUSTOMER SWITCHED TO THE THIRD REAGENT WEDGE SHORTLY AFTER THE QC FAILURES WERE OBSERVED WITH THE SECOND REAGENT WEDGE. ADJUSTMENT WAS PERFORMED WITH THE THIRD REAGENT WEDGE AND INITIALLY FAILED. ADJUSTMENT WAS REPEATED AND PASSED. AFTER THE PASSING ADJUSTMENT WAS OBTAINED, QC WAS OBSERVED TO BE IN RANGE. THE LEVEL SENSE DATA WAS CHECKED FOR ALL THREE REAGENT WEDGES, AND THERE WAS NO INDICATION OF ANY OCCURRENCES OF FOAM OR BUBBLES. THE LEVEL SENSE DATA FOR A RANDOM SAMPLE OF INDIVIDUAL ALLERGENS WAS CHECKED, AND THERE WAS NO INDICATION OF ANY OCCURRENCES OF FOAM OR BUBBLES. THE CAUSE OF THE FAILED ADJUSTMENT IS UNKNOWN, HOWEVER THE MOST LIKELY CAUSE BASED ON THE ERROR MESSAGES OBSERVED IN THE ERRORLOG FILE IS DUE TO INSUFFICIENT WASHING OF THE REACTION TUBE BECAUSE OF A LACK OF WATER IN THE WATER PROBE DUE TO NOT PRIMING THE INSTRUMENT, NOT PRIMING THE WATER PROBE, OR RUNNING OUT OF WATER. NO ERRORS OCCURRED AT THAT TIME FOR RUNNING OUT OF WATER. IT IS RECOMMENDED THAT THE CUSTOMER CHECK THE WATER SUPPLY AND CONFIRM THAT THE WATER TANK SCALE IS CORRECTLY CALIBRATED, AS INSUFFICIENT WASHING CAN CAUSE ELEVATED COUNTS. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE DISCORDANT RESULTS IS INCONCLUSIVE. THE CUSTOMER IS OPERATIONAL AFTER READJUSTMENT OF 3GALLERGY SPECIFIC IGE UNIVERSAL KIT REAGENT. THE IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT LOT 171 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 DISCORDANT 3G ALLERGY SPECIFIC IGE UNIVERSAL KIT RESULTS OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. QC RECOVERED OUTSIDE OF RANGE FOLLOWING THE INITIAL TESTING OF THE PATIENT RESULTS, PROMPTING THE CUSTOMER TO REPEAT THE PATIENT SAMPLES. IT WAS NOTED THAT THE QC FAILURES WERE MORE PERSISTENT FOR QUALITY CONTROL LEVEL 1. CONTROL REPEATS WERE PERFORMED; HOWEVER, THE RESULTS REMAINED OUTSIDE THE ACCEPTANCE RANGE. AS A RESULT, THE CUSTOMER PERFORMED A NEW ADJUSTMENT ON 10-JAN-2026 AT 5:42 AM; HOWEVER, THIS ADJUSTMENT SHOWED UNSATISFACTORY PERFORMANCE, WITH CV VALUES OUTSIDE ACCEPTABLE LIMITS FOR BOTH LOW AND HIGH LEVELS, IN ADDITION TO QUALITY CONTROL FAILURES FOR BOTH LEVELS (LEVEL 1 AND LEVEL 2). SUBSEQUENTLY, THE INSTRUMENT WAS ADJUSTED AGAIN ON 10-JAN-2026 AT 07:36 AM. THIS ADJUSTMENT WAS PERFORMED AFTER THE DAILY MAINTENANCE OF THE INSTRUMENT AND SHOWED GOOD PERFORMANCE, CONSISTENT WITH THE ASSAY'S HISTORICAL PERFORMANCE ON THE INSTRUMENT. THERE WAS NO INTERVENTION BY THE LOCAL CUSTOMER SERVICE ENGINEER (CSE) TEAM DURING THE EVALUATED PERIOD, AND NO TECHNICAL INTERVENTIONS OR MAINTENANCE ACTIVITIES WERE IDENTIFIED THAT COULD BE DIRECTLY RELATED TO THE REPORTED EVENT. THE LIMITATIONS SECTION OF THE IMMULITE 2000 3GALLERGY¿ SPECIFIC IGE UNIVERSAL KIT INSTRUCTIONS FOR USE (IFU) STATES: "A DEFINITIVE CLINICAL DIAGNOSIS SHOULD NOT BE MADE SOLELY ON THE BASIS OF AN IN VITRO ALLERGEN-SPECIFIC IGE RESULT. DIAGNOSIS SHOULD BE MADE BY THE PHYSICIAN ONLY AFTER ALL CLINICAL AND LABORATORY FINDINGS HAVE BEEN EVALUATED. [...] 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

FOLLOWING THE OBSERVATION OF QUALITY CONTROL (QC) FAILURES ON 10-JAN-2026 AT 00:28 AM FOR 3 GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE) ON AN IMMULITE 2000 XPI INSTRUMENT, THE CUSTOMER PERFORMED A ROUTINE RESET OF PATIENT SAMPLES WHICH WERE TESTED BETWEEN (B)(6) 2026 AT 12:46 PM AND (B)(6) 2026 AT 7:42 AM. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S), THE RESULTS WERE REPORTED DIRECTLY TO THE PATIENT. THERE WAS NO MEDICAL QUESTIONING. THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE CONSIDERED CORRECT. THE CUSTOMER STATED THAT 1 PATIENT SAMPLE RESULT WAS RECTIFIED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 3G ALLERGY SPECIFIC IGE UNIVERSAL KIT RESULTS.