IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SUPPORT CENTER (RSC) REGARDING ERRONEOUSLY DEPRESSED PATIENT RESULTS WITH ALLERGEN SPECIFIC IGE WHEN COMPARED TO AN ALTERNATE METHOD. THE INSTRUMENT IS AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM. QUALITY CONTROL WAS WITHIN ACCEPTABLE RANGES ON THE DATES OF TESTING. 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. NOTE: THE RESULTS FROM MAY 20, 2024 WILL BE REPORTED IN A SEPARATE MDR.

Description of Event or Problem

THE CUSTOMER REPORTED ERRONEOUS DEPRESSED RESULTS WHEN COMPARED TO AN ALTERNATE METHOD FOR ONE PATIENT WHEN USING ALLERGEN SPECIFIC IGE KIT LOT 121. THE INITIAL RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED USING AN ALTERNATE METHOD AND THE HIGHER REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS. A SECOND SAMPLE FROM THE SAME PATIENT WAS DRAWN AT A LATER DATE AND TESTING WAS REPEATED. THE REPEAT RESULTS REMAINED ERRONEOUSLY DEPRESSED WHEN COMPARED TO AN ALTERNATE METHOD. THE HIGHER REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ISSUE.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2024-00353 ON 21-JUN-2024. ADDITIONAL INFORMATION 09-AUG-2024: SIEMENS EVALUATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: BASED ON AN ASSESSMENT OF THE INSTRUMENT BY ON-SITE SIEMENS ENGINEERS, THERE IS NO INDICATION OF AN INSTRUMENT ISSUE THAT WOULD HAVE CAUSED THE NEGATIVE RESULTS OBSERVED BY THE CUSTOMER. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT POSSIBLE AS THE SAMPLE IS NOT AVAILABLE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT COULD BE RELATED TO THE POTENTIAL ALLERGEN BEING CONTAMINATED OR COMPROMISED. HOWEVER, THE CUSTOMER DID NOT PROVIDE MEDICAL HISTORY INDICATING THE RESULTS THAT WERE OBTAINED ARE INCORRECT. IMMULITE 2000 3GALLERGY SPECIFIC IGE LOT 121 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION D4, THE PRIMARY UDI NUMBER WAS UPDATED TO INCLUDE THE CORRECTED UNIQUE DEVICE IDENTIFIER (UDI) NUMBER. THE INITIAL MDR CONTAINED ONLY THE GLOBAL TRADE ITEM NUMBER (GTIN). IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.