BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST

    MDR report key: 4922226 · Received July 17, 2015

    Report

    Report Number
    3011393376-2015-01932
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 21, 2015
    Report Date
    August 20, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    KZH
    PMA / PMN Number
    K063146
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY. THE INFUSION SET STUCK THE PATIENT'S HAND; NO MEDICAL TREATMENT WAS REQUIRED. NO ADVERSE EVENT WAS REPORTED. THE INSERTION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464978 ACCU-CHEK ® LINKASSIST SPRING LOADED INSERTION DEVICE KZH ROCHE DIABETES CARE, INC. NA 121

    Patients

    Seq Age Sex Outcome Treatment
    1