BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000/IMMULITE 2000 XPI GASTRIN

    MDR report key: 7041464 · Received November 17, 2017

    Report

    Report Number
    2432235-2017-00616
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 26, 2017
    Report Date
    December 19, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    CGC
    UDI-DI
    00630414961521
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2432235-12/19/2017-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2017-00616 WAS FILED ON 17-NOV-2017. ADDITIONAL INFORMATION (06-DEC-2017): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT BIOTIN INTERFERES WITH THE GASTRIN ASSAY ON THE IMMULITE 2000/ IMMULITE 2000 XPI PLATFORM. AT BIOTIN CONCENTRATIONS OF >2 NG/ML A NEGATIVE 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 2000/ IMMULITE 2000 XPI 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.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION (12/18/2017): BASED ON INPUT FROM THE (B)(4) RECALL COORDINATOR ON 12/18/2017 THIS RECALL WAS RE-SUBMITTED TO THE (B)(4) OFFICE ([email protected]). THE CRR REPORTING NUMBER INDICATED IS INCORRECT AND WAS CHANGED TO 2432235-12/19/2017-004-C. IN ADDITION IT WAS INDICATED THAT AN "URGENT MEDICAL DEVICE RECALL (UMDR) WAS SENT TO US CUSTOMERS. THIS IS INCORRECT AS AN "URGENT MEDICAL DEVICE CORRECTION (UMDC)" WAS SENT TO US CUSTOMERS ON DECEMBER 13, 2017.

    Additional Manufacturer Narrative · 1

    SIEMENS IS EVALUATING THE ISSUE.

    Description of Event or Problem · 1

    SIEMENS TECHNICAL OPERATIONS INTERNAL INVESTIGATION HAS IDENTIFIED THAT DISCORDANT FALSELY LOW RESULTS WERE OBTAINED ON TWO INVESTIGATIONAL SAMPLES ON AN IMMULITE 2000/ IMMULITE 2000 XPI INSTRUMENT WHEN USING THE GASTRIN ASSAY. THE TWO INVESTIGATIONAL SAMPLES WERE SPIKED WITH BIOTIN AT MULTIPLE CONCENTRATIONS AND RUN FOR INVESTIGATIONAL PURPOSES ON AN IMMULITE 2000/IMMULITE 2000 XPI INSTRUMENT. THE RESULTS OF THE TWO SAMPLES SPIKED WITH 19 NG/ML OF BIOTIN WERE FALSELY LOW WITH A BIAS OF -52% AND -51% RESPECTIVELY COMPARED TO RESULTS OF THE TWO SAMPLES WITHOUT BIOTIN. THERE WERE NO PATIENT SAMPLES IMPACTED AS THIS WAS FOR INVESTIGATIONAL PURPOSES ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822929 IMMULITE 2000/IMMULITE 2000 XPI GASTRIN IMMULITE 2000/IMMULITE 2000 XPI GASTRIN CGC SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000/IMMULITE 2000 XPI GASTRIN 252 00630414961521

    Patients

    Seq Age Sex Outcome Treatment
    1