BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST

    MDR report key: 4102781 · Received September 19, 2014

    Report

    Report Number
    1823260-2014-07199
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 29, 2013
    Report Date
    November 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KZH
    PMA / PMN Number
    K063146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSERTION DEVICE WILL OCCASIONALLY RELEASE THE INFUSION SET WHEN HE IS NOT PRESSING THE RELEASE BUTTON. HE REPORTED HE HAS BEEN "PRICKED" BY THE CANNULA A FEW TIMES, BUT HE HAS NOT REQUIRED MEDICAL TREATMENT. THE ALLEGED PRODUCT WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583941 ACCU-CHEK ® LINKASSIST SPRING LOADED INSERTION DEVICE KZH ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1