BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDERLINK

    MDR report key: 2172435 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01802
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    December 1, 2009
    Report Date
    May 30, 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

    NO PRODUCT WAS RETURNED FOR EVAL. AS THE LOT NUMBER WAS NOT AVAILABLE, THE COMPLAINT COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    PT REPORTED THAT OVER THE PAST 1.5 YEARS, 4-5 INFUSION SETS LEAKED INSULIN AT THE CANNULA. BLOOD GLUCOSE ELEVATED AS HIGH AS 220 MG/DL. PT DELIVERED INSULIN VIA PEN AND INFUSION DEVICE TO CORRECT HYPERGLYCEMIA. NORMAL BLOOD GLUCOSE IS 90 MG/DL. ALLEGED INFUSION SETS WERE DISCARDED AND WILL NOT BE RETURNED FOR EVAL. PT WAS UNABLE TO PROVIDE THE INFUSION SET LOT NUMBERS. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADD'L INFO WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR INSULIN INFUSION DEVICE| INSULIN