BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE/IMMULITE1000 GASTRIN

    MDR report key: 7041484 · Received November 17, 2017

    Report

    Report Number
    2432235-2017-00619
    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
    00063414964034
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2432235-12/19/2017-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED ON NOVEMBER 17, 2017. FOLLOW UP 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 IS INCORRECT AND WAS CHANGED TO (B)(4). AN "URGENT MEDICAL DEVICE CORRECTION (UMDC)" WAS SENT TO US CUSTOMERS ON DECEMBER 13, 2017.

    Additional Manufacturer Narrative · 1

    SIEMENS IS EVALUATING THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2017-00619 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/IMMULITE 1000 PLATFORM. AT BIOTIN CONCENTRATIONS OF >2 NG/ML A NEGATIVE BIAS THAT EXCEEDS 10% HAS BEEN OBSERVED ON IMMULITE/IMMULITE 1000 PLATFORMS. THIS ISSUE AFFECTS PREVIOUSLY MANUFACTURED, IN-DATE, AND FUTURE LOTS. THE IMMULITE/IMMULITE 1000 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 · 1

    SIEMENS TECHNICAL OPERATIONS INTERNAL INVESTIGATION HAS IDENTIFIED THAT DISCORDANT FALSELY LOW RESULTS WERE OBTAINED ON TWO INVESTIGATIONAL SAMPLES ON AN IMMULITE/ IMMULITE 1000 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/IMMULITE 1000 INSTRUMENT. THE RESULTS OF THE TWO SAMPLES SPIKED WITH 19 NG/ML OF BIOTIN WERE FALSELY LOW WITH A BIAS OF -51% AND -52% 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
    822930 IMMULITE/IMMULITE1000 GASTRIN IMMULITE/IMMULITE 1000 GASTRIN CGC SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE/IMMULITE 1000 GASTRIN 347 00063414964034

    Patients

    Seq Age Sex Outcome Treatment
    1