BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1833130 · Received September 9, 2010

    Report

    Report Number
    2183996-2010-01840
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, MOTHER REPORTED HYPERGLYCEMIA DUE TO LEAKY LUER ON INFUSION SET. BLOOD GLUCOSE WAS "OVER 400" MG/DL. PATIENT DOES NOT HAVE A TARGET BLOOD GLUCOSE RANGE. HYPERGLYCEMIA WAS CORRECTED BY AN INSULIN INJECTION. MOTHER REPORTS PATIENT IS A "CRITICAL BRITTLE DIABETIC." PATIENT FELT WETNESS WHERE INSULIN WAS LEAKING. LEAK ORIGINATED AT LUER LOCK CONNECTION AND INFUSION SET LUER LOCK WAS NOT BROKEN OR CRACKED. INFUSION DEVICE IS WORN IN A PLASTIC CASE. NO ALERTS OR ERRORS WERE RECEIVED ON INFUSION DEVICE. INFUSION SET AND INSULIN CARTRIDGE WERE BEING USED WITHIN SPECIFICATIONS. IT IS UNKNOWN WHEN ADAPTER WAS LAST CHANGED. THERE WAS NO BLOOD IN INFUSION TUBING. INSULIN CARTRIDGE WAS NOT REUSED. INFUSION SET WAS NOT DISCONNECTED OR DISLODGED. INFUSION DEVICE TIME AND BASAL RATES WERE PROGRAMMED CORRECTLY. INSULIN WAS NOT EXPIRED. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER. A SMALL AMOUNT OF INSULIN LEAKED ON OUTSIDE OF INFUSION DEVICE AND THIS AREA WAS WIPED DRY. MOTHER REPORTED 3 INFUSION SETS FROM BOX HAVE HAD LEAKY LUERS. INFUSION SETS WERE REPLACED AND REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 627101

    Patients

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