IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT

Additional Manufacturer Narrative

MDR 1219913-2024-00290 WAS FILED ON APRIL 16, 2024. ADDITIONAL INFORMATION MAY 7, 2024: SIEMENS REVIEWED THE MAIN DATABASE AND SPY FILES. THE FILES DID NOT SHOW ANY PIPETTING ISSUES OR LEVEL SENSE ISSUES. ALL AVAILABLE STABILITY DATA FOR PISTACHIO ALLERGEN (F203) LOT 626 HAS BEEN REVIEWED, IN ADDITION TO THE KIT RELEASE FOR 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (L2KUN) 106. NO ISSUES WERE NOT IDENTIFIED IN EITHER THE ALLERGEN STABILITY DATA OR THE 3GALLERGY SPECIFIC IGE UNIVERSAL KIT 106. BASED ON AVAILABLE INFORMATION SAMPLING HANDLING CANNOT BE RULED OUT. NO PRODUCT PROBLEM IDENTIFIED TO DATE. THE CUSTOMER PROVIDED AN ADDITIONAL PISTACHIO TEST RESULT FOR PATIENT ID (B)(6) GENERATED ON (B)(6) 2024. THE RESULT WAS 11.5 KU/L WHICH WAS SIMILAR TO THE HISTORICAL RESULTS. SIEMENS CONTINUES TO INVESTIGATE.

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SUPPORT CENTER (RSC) REGARDING TWO FALSELY DEPRESSED PATIENT RESULTS WITH ALLERGEN SPECIFIC IGE. THE INSTRUMENT IS AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM. QUALITY CONTROL (QC) RECOVERED WITHIN RANGE. NO ERRORS WERE OBSERVED IN SAMPLE PROCESSING DURING THE REPEAT PERIOD AND THE CUSTOMER ALSO REPORTED THAT THE EQUIPMENT DID NOT DISPLAY CRITICAL FLAGS DURING THIS PERIOD. 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." SIEMENS IS INVESTIGATING. IMMULITE 2000 3GALLERGY¿ SPECIFIC IGE UNIVERSAL KIT IS MARKETED IN THE UNITED STATES UNDER MATERIAL NUMBER 10708840. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THIS PRODUCT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ON (B)(6) 2024 TWO FALSELY DEPRESSED PATIENT RESULTS, COMPARED TO REPEAT TESTING, WERE OBTAINED WITH ALLERGEN SPECIFIC IGE, LOT # 626 ON IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM, SERIAL NUMBER: (B)(6) . THE INITIAL PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPROCESSED ON THE ORIGINAL INSTRUMENT AND WERE HIGHER. CORRECTED REPORTS WERE ISSUED WITH THE REPROCESSED RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

Additional Manufacturer Narrative

MDR 1219913-2024-00290 WAS FILED ON APRIL 16, 2024 AND MDR 1219913-2024-00290 SUPPLEMENTAL 1 WAS FILED ON MAY 30, 2024. ADDITIONAL INFORMATION JUNE 3, 2024. WHEN EVALUATING THE LEVEL SENSING, SIEMENS LOOKS FOR CONSISTENT ENCODER (ENC) VALUE CHANGES AS THE PROBE DESCENDS INTO THE SAMPLE TUBE, ALLERGEN VIAL AND THE REAGENT (THE SPE REAGENT). IN THIS FILE REVIEW IT WAS NOTED THAT BOTH AFFECTED SAMPLES HAD INCONSISTENCIES NOTED IN THE PISTACHIO ALLERGEN LEVEL SENSING. BOTH SAMPLE AND REAGENT LEVEL SENSING WERE ACCEPTABLE AND APPROPRIATE. THE AFFECTED SAMPLES HAD ENCODER VALUES AT -5138 AND -5226 FOR THE PISTACHIO ALLERGEN BUT THEN 90 MINS LATER THE ENCODER VALUES DROPS TO -6537 AND INCREMENTS AS APPROPRIATE. THIS COULD BE INDICATIVE OF FOAM OR BUBBLES IN THE ALLERGEN WEDGE. THE CUSTOMER IS OPERATIONAL. ISSUE RESOLVED VIA ROUTINE TROUBLESHOOTING. THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES HAVE BEEN UPDATED IN SECTION H6.