BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER

    MDR report key: 2081691 · Received April 13, 2011

    Report

    Report Number
    2183996-2011-00991
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVRY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS - NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(4) 2011, PATIENT REPORTED ELEVATED BLOOD GLUCOSE DUE TO A KINKED INFUSION CANNULA AND INSULIN LEAKAGE UNDERNEATH THE INFUSION SET ADHESIVE. THE INFUSION SET HAD BEEN IN USE FOR 2 DAYS, AND BLOOD GLUCOSE ELEVATED TO 250 MG/DL. NORMAL BLOOD GLUCOSE IS 140 MG/DL, AND PATIENT BOLUSED THROUGH THE INFUSION DEVICE TO TREAT HYPERGLYCEMIA. PATIENT SMELLED INSULIN AND FELT THERE WAS INSULIN LEADING UNDERNEATH THE ADHESIVE, BUT SHE REPORTED THE INSULIN DRIED UP BEFORE THE HEADSET WAS REMOVED. HEADSET WAS INSERTED AT 30-45 DEGREE ANGLE, AND THE KINK WAS LOCATED AT THE END OF THE CANNULA. PATIENT INSERTED A DIFFERENT TYPE OF INFUSION SET AND SAID SHE WOULD CONTINUE TO BOLUS TO DECREASE BLOOD GLUCOSE. NO PRODUCT WAS REQUESTED FOR EVALUATION. PRODUCT WAS REPLACED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ATTEMPT WAS MADE TO FOLLOW-UP WITH PATIENT, AND THIS WAS NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INSULIN INFUSON SET FPA ROCHE INSULIN DELIVRY SYSTEMS INC. NA 645172

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR INSULIN INFUSION DEVICE| INSULIN