IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2024-00022 ON 09-FEB-2024. ADDITIONAL INFORMATION 14-MAR-2024: SIEMENS INVESTIGATION ASSESSED ADJUSTOR COUNTS PER SECOND (CPS) AND SLOPE FROM KIT RELEASE DATA AND FROM THE ADJUSTMENT INFORMATION PROVIDED BY THE CUSTOMER. THE ADJUSTMENT FROM 11-JAN-2024, WHICH WAS USED AT THE TIME OF THE ERRONEOUSLY DEPRESSED RESULTS, WAS WITHIN SPECIFICATION. HOWEVER, THE ADJUSTMENT FROM 20-JAN-2024 USING THE REAGENTS IN USE WHEN THE ERRONEOUSLY DEPRESSED RESULTS WERE GENERATED, COMPARED TO KIT RELEASE DATA AND THE PREVIOUS ADJUSTMENT PERFORMED ON 11-JAN-2024, SHOWED DEPRESSED ADJUSTER CPS VALUES. THE CUSTOMER USED A NEW 3GALLERGY SPECIFIC IGE (SPE) REAGENT WEDGE, FROM THE SAME LOT, AND REPEATED THE ADJUSTMENT ON 20-JAN-2024. AFTER THE REAGENT WEDGE WAS REPLACED, THE QUALITY CONTROL (QC) RECOVERED WITHIN ACCEPTABLE RANGES. BASED ON THE AVAILABLE INFORMATION, CONTAMINATION OF THE REAGENT CANNOT BE EXCLUDED. THE CUSTOMER IS OPERATIONAL AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE UNIVERSAL KIT, LOT 103, 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.

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 AFTER THE CUSTOMER SWITCH REAGENT PACK. NO PATIENT SAMPLES WERE PROCESSED WHILE QC WAS OUT OF 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

ON (B)(6) 2024 TWO FALSELY DEPRESSED PATIENT RESULTS, COMPARED TO REPEAT TESTING, WERE OBTAINED WITH ALLERGEN SPECIFIC IGE, LOT # 103. THE INSTRUMENT IS AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM, SERIAL NUMBER: (B)(6). INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIANS. THE SAMPLES WERE REPROCESSED ON ALTERNATE INSTRUMENTS AND THE RESULTS WERE HIGHER. THE REPROCESSED RESULTS WERE REPORTED, SINCE QUALITY CONTROL (QC) WAS IN RANGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ISSUE.