BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 4220161 · Received November 3, 2014

    Report

    Report Number
    1823260-2014-08443
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    November 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED ELEVATED BLOOD GLUCOSE DUE TO A LEAKING INSULIN CARTRIDGE. THE CUSTOMER WAS ABLE TO SUCCESSFULLY SELF-TREAT. NO ADVERSE EVENT REPORTED. THE CARTRIDGE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701539 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA 32416349

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED INSULIN