BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D

    MDR report key: 2170885 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01864
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT REPORTED, THE INFUSION SET IS LEAKING AT THE INFUSION SITE AND AT THE LUER CONNECTION. HE NOTICED THE LEAK AT THE INFUSION SITE WHEN THE HEADSET ADHESIVE BECAME WET. THE INFUSION SITE IS ON HIS BACK AND THERE IS NO SCAR TISSUE IN THE AREA. HE IS UNSURE IF INSULIN IS LEAKING FROM HIS BODY OR FROM THE HEADSET. THE ADAPTER HAS BEEN IN USE FOR 10 DAYS AND THERE IS NO LEAKAGE AT THE LUER WHEN A DIFFERENT TYPE OF INFUSION SET IS USED. HE STATED, THE INFUSION SET WAS CORRECTLY ATTACHED TO THE ADAPTER AND WAS NOT DAMAGED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 32403020

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR INSULIN INFUSION PUMP| INSULIN