BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST

    MDR report key: 3061785 · Received April 16, 2013

    Report

    Report Number
    2183996-2013-00674
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    January 1, 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
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PATIENT REPORTED THAT THE LOCKING AND SAFETY MECHANISM ON HER INSERTION DEVICE WAS NOT FUNCTIONING AND THE DEVICE WAS RELEASING UNINTENTIONALLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INSERTION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162381 ACCU-CHEK ® LINKASSIST SPRING LOADED INSERTION DEVICE KZH ROCHE DIABETES CARE AG NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female CLONDINE| IBUPROFEN| LISINOPRIL WITH HCTZ| MAGNESIUM| NOVALOG| SIMASTAPIN| TRAMA-DOL HCL| TUMS| VITAMIN D3| MAGNESIUM| TUMS| SIMASTAPIN| TRAMA-DOL HCL| NOVALOG| VITAMIN D3| IBUPROFEN| CLONDINE| LISINOPRIL WITH HCTZ