BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® SYSTEM

    MDR report key: 5170962 · Received October 23, 2015

    Report

    Report Number
    9610806-2015-00041
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    September 25, 2015
    Report Date
    November 3, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZG
    PMA / PMN Number
    K083463
    Removal / Correction Number
    Z-2450-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL MDR WAS SUBMITTED 2015-10-23. SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED COMPLAINTS OF AN INCREASE IN THE RATE OF "ABNORMAL ASSAY" ERRORS AND CALIBRATION FAILURES WITH THE DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE LOTS 15175MA, 15204MA, 15246MA AND 15267MA. THE ERRORS CAN OCCUR ON CALIBRATION, QC AND/OR PATIENT SAMPLES. AS STATED IN THE DIMENSION VISTA OPERATOR'S GUIDE, RESULTS WITH "ABNORMAL ASSAY" FLAGS ARE NOT REPORTABLE. SIEMENS ISSUED AN URGENT MEDICAL DEVICE RECALL COMMUNICATION (B)(4) DATED NOVEMBER 2015 TO CUSTOMERS WHO HAD ORDERED THE IMPACTED LOTS ADVISING THEM TO DISCONTINUE THE USE OF THE LOT.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING AN INCREASE IN THE RATE OF "ABNORMAL ASSAY" ERRORS AND CALIBRATION FAILURES WITH THE DIMENSION VISTA(R) B2MIC FLEX(R) REAGENT CARTRIDGE LOT 15204MA. THE ERRORS CAN OCCUR ON CALIBRATION, QC, AND/OR PATIENT SAMPLES. AS STATED IN THE DIMENSION VISTA OPERATOR'S GUIDE, RESULTS WITH ABNORMAL ASSAY FLAGS ARE NOT REPORTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF OBTAINING ABNORMAL ASSAY E143 FLAGS ON CALIBRATION SAMPLES WITH THE BETA-2 MICROGLOBULIN (B2MIC) FLEX (R) REAGENT CARTRIDGE LOT 15204MA ON THE DIMENSION VISTA INSTRUMENT. THE ACCOUNT WAS UNABLE TO OBTAIN AN ACCEPTABLE CALIBRATION. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE ABNORMAL ASSAY FLAGS ON B2MIC RESULTS. THERE IS NO INDICATION OF ADVERSE PATIENT IMPACT DUE THE ABNORMAL ASSAY FLAGS ON B2MIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701548 DIMENSION VISTA® SYSTEM B2MIC FLEX® REAGENT CARTRIDGE AND URINE STABILIZER JZG SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 15204MA

    Patients

    Seq Age Sex Outcome Treatment
    1