BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST

    MDR report key: 3837992 · Received May 29, 2014

    Report

    Report Number
    1823260-2014-03796
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 22, 2014
    Report Date
    August 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
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT REPORTED THE INSERTION ASSIST DEVICE DOES NOT RELEASE THE HEADSET IMMEDIATELY AFTER PRESSING THE BUTTON BUT IT RELEASES IT MINUTES LATER. PATIENT STATED THE ISSUE BEGAN ABOUT 2 WEEKS AGO. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED INSERTION ASSIST DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315272 ACCU-CHEK ® LINKASSIST SPRING LOADED INSERTION DEVICE KZH ROCHE DIAGNOSTICS NA 119

    Patients

    Seq Age Sex Outcome Treatment
    1