BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER

    MDR report key: 2070438 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01108
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 167 MG/DL DUE TO LEAKING AT THE INFUSION TUBING CONNECTION TO THE HEADSET. HER NORMAL BLOOD GLUCOSE RANGE IS 80-100 MG/DL. SHE STATED SHE MAKES SURE THE CONNECTION IS SECURE AND SHE DOES NOT OFTEN DISCONNECT FROM THE INFUSION SITE. SHE STATED THE ISSUE ONLY OCCURS WHEN THE INFUSION SITE IS LOCATED AT HER SIDE AND SPECULATES TURNING AND TWISTING CAUSES THE LEAK. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE REPLACED. THE PT WILL RETURN UNUSED INFUSION SETS FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INSULIN| INSULIN INFUSION PUMP