BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDERLINK

    MDR report key: 2141069 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01598
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 11, 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. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    PT REPORTED THAT SHE OFTEN EXPERIENCES ITCHING AT THE INFUSION SITE AND THAT THE SITE OF INSERTION IS LARGER THAN THE PREVIOUS TYPE OF INFUSION SET SHE USED. PT EXPERIENCED ELEVATED BLOOD GLUCOSE OF 20 MMOL/L (360 MG/DL). PT ATTEMPTED TO CORRECT HYPERGLYCEMIA, BUT THIS WAS NOT SUCCESSFUL. SHE THEN REALIZED THE SELF-ADHESIVE OF THE INFUSION SET WAS WET AND INSULIN HAD LEAKED BETWEEN THE TUBE AND HEADSET. PT CHANGED THE INFUSION SET AND WAS "OKAY" AFTER. ALLEGED INFUSION SET WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL. 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 TENDERLINK INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 645163

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION DEVICE