BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST

    MDR report key: 3092129 · Received May 3, 2013

    Report

    Report Number
    2183996-2013-00783
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 25, 2013
    Report Date
    August 1, 2025
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    KZH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER, NO INVESTIGATION COULD BE PERFORMED. THEREFORE, THE COMPLAINT CANNOT BE VERIFIED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSERTION DEVICE UNINTENTIONALLY RELEASED THE INFUSION SET INTO THE PATIENT'S SKIN. THE INFUSION SET WAS STUCK IN THE DEVICE AND WOULD NOT COME OUT, AND WHEN THE DEVICE WAS LIFTED AWAY, THE INFUSION SET WAS RELEASED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INSERTION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193692 ACCU-CHEK ® LINKASSIST SPRING LOADED INSERTION DEVICE KZH ROCHE DIABETES CARE AG 00700006958 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female