BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST

    MDR report key: 3070843 · Received April 22, 2013

    Report

    Report Number
    2183996-2013-00724
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 9, 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
    KS, 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 A REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED HAVING CONCERNS WITH THE INSERTION ASSIST DEVICE. PATIENT STATED SHE IS HAVING CONCERNS WITH THE RELEASE BUTTON. PATIENT REPORTED IT TOOK HER ABOUT 20 MINUTES TO GET THE INSERTION ASSIST DEVICE TO WORK; IS USING IT CORRECTLY. PATIENT STATED SHE KEPT PRESSING THE BUTTON SEVERAL TIMES AND FINALLY IT EJECTED THE INFUSION SET. PATIENT REPORTED THAT ON ONE OCCASION THE INSERTION ASSIST DEVICE UNINTENTIONALLY FIRED INTO ANOTHER BODY PART. PATIENT STATED SHE DOES NOT THINK THAT SHE OPPRESSED THE BUTTON TO FIRE IT; WHEN SHE TURNED IT AWAY, IT FIRED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172480 ACCU-CHEK ® LINKASSIST SPRING LOADED INSERTION DEVICE KZH ROCHE DIABETES CARE AG NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female ASPRIN| HUMALOG| HUMALOG| ASPRIN