BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D LINK

    MDR report key: 2141047 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01604
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT REPORTED THAT THE INFUSION SET WAS LEAKY BETWEEN THE CANNULA, SELF-ADHESIVE, AND CONNECTOR PLATE. THIS OCCURRED SEVERAL TIMES, AND BLOOD GLUCOSE ELEVATED AS HIGH AS 200 MG/DL. NORMAL BLOOD GLUCOSE IS 120 MG/DL, AND PT DELIVERED CORRECTION BOLUSES THROUGH THE INFUSION DEVICE. HE WAS ABLE TO SMELL INSULIN DUE TO THE LEAK. INFUSION SET WAS REQUESTED FOR EVAL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADDITIONAL INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D LINK INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR INSULIN| INSULIN INFUSION DEVICE