IMMULITE 2000/IMMULITE 2000 XPI CEA

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT BIOTIN INTERFERES WITH THE CEA ASSAY ON THE IMMULITE 2000/IMMULITE 2000 XPI PLATFORM. AT BIOTIN CONCENTRATIONS OF >2 NG/ML A POSITIVE BIAS THAT EXCEEDS 10% HAS BEEN OBSERVED ON IMMULITE 2000/IMMULITE 2000 XPI PLATFORMS. THIS ISSUE AFFECTS PREVIOUSLY MANUFACTURED, IN-DATE, AND FUTURE LOTS. THE IMMULITE PLATFORM INSTRUCTIONS FOR USE (IFU'S) CURRENTLY DO NOT HAVE BIOTIN LISTED AS A POTENTIAL INTERFERENT. AN URGENT FIELD SAFETY NOTICE (UFSN) IMC 18-02.A.OUS WAS SENT OUT TO OUS CUSTOMERS AND AN URGENT MEDICAL DEVICE RECALL (UMDR) IMC18-02.A.US WAS SENT TO US CUSTOMERS ON DECEMBER 13, 2017. THE UFSN AND UMDR INFORMS THE CUSTOMERS OF BIOTIN INTERFERENCE ON ALL AFFECTED IMMULITE ASSAYS. SIEMENS WILL UPDATE ALL IFU'S WITH THE APPROPRIATE BIOTIN INFORMATION.

Description of Event or Problem

SIEMENS TECHNICAL OPERATIONS INTERNAL INVESTIGATION HAS IDENTIFIED THAT DISCORDANT FALSELY HIGH RESULTS WERE OBTAINED ON TWO INVESTIGATIONAL SAMPLES ON AN IMMULITE 2000/ IMMULITE 2000 XPI INSTRUMENT WHEN USING THE CARCINOEMBRYONIC (CEA) ASSAY. THE INVESTIGATIONAL SAMPLE WAS SPIKED WITH BIOTIN AT MULTIPLE CONCENTRATIONS, AND RUN FOR INVESTIGATIONAL PURPOSES ON AN IMMULITE 2000/IMMULITE 2000 XPI INSTRUMENT. THE RESULT OF THE SAMPLE SPIKED WITH 1200 NG/ML OF BIOTIN WERE FALSELY HIGH WITH A BIAS OF +31% COMPARED TO THE RESULT OF THE SAMPLE WITHOUT BIOTIN. THERE WERE NO PATIENT SAMPLES IMPACTED AS THIS WAS FOR INVESTIGATIONAL PURPOSES ONLY.

Additional Manufacturer Narrative

THE INITIAL MDR WAS FILED ON DECEMBER 14, 2017. CORRECTED INFORMATION (12/18/2017): BASED ON INPUT FROM THE (B)(6) RECALL COORDINATOR ON 12/18/2017 THIS RECALL WAS RE-SUBMITTED TO THE (B)(6) OFFICE (B)(4). THE CRR REPORTING NUMBER INDICATED IN SECTION H9 IS INCORRECT AND WAS CHANGED TO (B)(4). AN "URGENT MEDICAL DEVICE CORRECTION (UMDC)" WAS SENT TO US CUSTOMERS ON DECEMBER 13, 2017.