BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK LINKASSIST

    MDR report key: 3080916 · Received April 26, 2013

    Report

    Report Number
    2183996-2013-00749
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 10, 2013
    Report Date
    August 1, 2025
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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 A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE LINKASSIST (SERIAL NO. (B)(4)) MEETS THE SPECIFICATIONS. RESULT THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THE DEVICE WERE OPTICALLY AND TECHNICALLY CONTROLLED AND PASSED ALL THE TESTS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INSERTION ASSIST DEVICE TRIGGERS WITH DELAY. PATIENT STATED THE DEVICE TRIGGERED FIRST WHEN SHE REMOVED IT FROM THE SKIN; HAS NOT HURT HERSELF OR OTHERS DUE TO THIS ISSUE. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INSERTION ASSIST DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181264 ACCU-CHEK LINKASSIST INFUSION SET INSERTION ASSIST DEVICE FPA ROCHE DIABETES CARE AG 00700006958 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female