BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST

    MDR report key: 3093517 · Received May 6, 2013

    Report

    Report Number
    2183996-2013-00791
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 25, 2013
    Report Date
    August 1, 2025
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    KZH
    PMA / PMN Number
    K063146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LINKASSIST INSERTION DEVICE MEETS THE SPECIFICATIONS, AND THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THE DEVICE WAS OPTICALLY AND TECHNICALLY CONTROLLED AND PASSED ALL TESTS. THE HEADSET WAS INVESTIGATED WITHOUT FINDING ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(4) 2013 A PATIENT INDICATED THAT HIS LINK ASSIST DID NOT FIRE UPON INITIAL TRY ALTHOUGH HE DID HEAR A CLICK. AS HE ATTEMPTED TO RESET THE DEVICE TO START POSITION, THE DEVICE FIRED AND THE INFUSION SET SHOT ACROSS THE ROOM WITHOUT BUTTON PRESS FROM THE CUSTOMER. HE INSERTED A SECOND INFUSION SET WHICH DID NOT FIRE AND IS STUCK IN THE DEVICE. THERE WAS NO INJURY OR DAMAGE REPORTED FROM THIS EVENT AND THERE WAS NO OUTSIDE INTERVENTION REQUIRED. THE INFUSION SET AND INSERTION DEVICE ARE BEING REQUESTED FOR EVALUATION DUE TO THE UNINTENDED RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197332 ACCU-CHEK ® LINKASSIST SPRING LOADED INSERTION DEVICE KZH ROCHE DIABETES CARE AG NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male ACCUCHEK AVIVA COMBO| NOVOLOG| NOVOLOG| ACCUCHEK AVIVA COMBO