IMMULITE 2000 3GALLERGY SPECIFIC IGE

Additional Manufacturer Narrative

THE INITIAL MDR 2432235-2018-00226 WAS FILED ON 29-MAY-2018. SUPPLEMENTAL MDR 2432235-2018-00226_S1 WAS FILED ON JUNE 26TH 2018. ADDITIONAL INFORMATION (29-JUN-2018): A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE KIT RELEASE DATA FOR IMMULITE 2000 E2 (DOG) ALLERGEN LOT 602. THE RELEASE DATA INDICATES THAT THE ALLERGEN IS PERFORMING AS EXPECTED. THE HSC SPECIALIST REVIEWED THE RESULTS FROM THE TESTING PERFORMED AT THE SIEMENS TECHNICAL SUPPORT LABORATORY (TSL). THE HSC SPECIALIST STATED THAT THE RESULT FROM THE TSL STUDY INDICATES THAT THE ASSAY IS DETECTING THE E2 ALLERGEN AND THE DIFFERENCE IN RESULTS WITH THE ALTERNATE METHOD IS ATTRIBUTED TO METHOD DIFFERENCES. THE CAUSE OF THE DISCORDANT FALSE NEGATIVE RESULT ON THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 (DOG EPITHELIUM) ALLERGEN RESULT IS UNKNOWN. THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 (DOG EPITHELIUM) ALLERGEN IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Additional Manufacturer Narrative

THE INITIAL MDR 2432235-2018-00226 WAS FILED ON 29-MAY-2018. ADDITIONAL INFORMATION (06-JUN-2018): REPEAT TESTING WITH A FRESH SAMPLE OBTAINED FROM THE PATIENT WAS PERFORMED ON THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 (DOG EPITHELIUM) ALLERGEN AND RESULTED AS 0.4 KU/L (CLASS I), WHICH INDICATES LOW REACTIVITY FOR INDIVIDUAL/ PANEL ALLERGENS. THIS SAMPLE WAS ALSO TESTED ON THE ALTERNATE METHOD AND RESULTED AS CLASS 4. A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST STATED THAT DIFFERENCE IN RESULTS COULD BE DUE TO A DIFFERENCE IN METHODOLOGIES. BOTH THE IMMULITE AND THE ALTERNATE METHOD ARE REPORTING REACTIVE RESULTS WHICH INDICATE THE PATIENT IS HAVING A REACTION TO THE E2 ALLERGEN. THE DIFFERENCE IN THE TWO METHODS CAN BE ATTRIBUTED TO THE DIFFERENT ARCHITECTURES OF THE METHODS AS WELL AS DIFFERENCES IN MATERIALS USED TO MAKE THE REAGENTS. THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE ASSAY DOES NOT HAVE A CLAIM THAT IT WILL CORRELATE TO OTHER METHODS. ADDITIONAL INFORMATION (25-JUN-2018): THE SAMPLE WAS SENT TO THE SIEMENS TECHNICAL SUPPORT LABORATORY (TSL) FOR TESTING AND WAS RECEIVED AT THE TSL. ADDITIONAL INFORMATION (26-JUN-2018): REPEAT TESTING OF THE SAMPLE WAS PERFORMED AT THE SIEMENS TSL ON THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 (DOG EPITHELIUM) ALLERGEN. THE MEAN RESULT WAS 0.36 KU/L (CLASS I), WHICH IS IN ALIGNMENT WITH THE RESULTS OBTAINED AT THE CUSTOMER'S SITE. THE CAUSE OF THE DISCORDANT FALSE NEGATIVE RESULT ON THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 (DOG EPITHELIUM) ALLERGEN RESULT IS UNKNOWN. THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 (DOG EPITHELIUM) ALLERGEN IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. METHOD, RESULT AND CONCLUSION CODES HAVE BEEN UPDATED IN SECTION H6.

Additional Manufacturer Narrative

A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE KIT RELEASE DATA FOR IMMULITE 2000 E2 (DOG EPITHELIUM) ALLERGEN LOT 602. THE RELEASE DATA INDICATES THAT THE ALLERGEN IS PERFORMING AS EXPECTED. THE ISSUE APPEARS TO BE A POSSIBLE SAMPLING ISSUE WITH THE SYSTEM OR A SAMPLE SPECIFIC ISSUE. THERE IS NO MORE SAMPLE AVAILABLE OF THE ORIGINAL SAMPLE FOR REPEAT TESTING OR TROUBLESHOOTING. A RE-DRAW FROM THE PATIENT HAS BEEN REQUESTED. THE CAUSE OF THE DISCORDANT, FALSE NEGATIVE RESULT ON THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 (DOG EPITHELIUM) ALLERGEN IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

Description of Event or Problem

A DISCORDANT, FALSE NEGATIVE RESULT WAS OBTAINED ON THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 (DOG EPITHELIUM; REF (B)(4); 510(K) # K013134) ALLERGEN. THE TEST WAS ORDERED BY THE PATIENT'S MOTHER AND THE RESULT WAS REPORTED TO THE PATIENT. THE SAME SAMPLE WAS ALSO TESTED ON AN ALTERNATE METHOD WITH THE EUROIMMUN ALLERGEN PANEL (INHALANT PANEL AND INCLUDES E2 ALLERGEN) AND RESULTED POSITIVE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE FALSE NEGATIVE RESULT ON THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 ALLERGEN. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENT DUE TO THE FALSE NEGATIVE RESULT ON THE IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE FOR E2 ALLERGEN.