BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPIDLINK INFUSION SET

    MDR report key: 2110215 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01452
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEM 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 THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED, THE INFUSION SET WAS LEAKY UNDER THE SELF ADHESIVE. PATIENT STATED, THIS ISSUE OCCURRED SEVERAL TIMES. PATIENT REPORTED, HER BLOOD GLUCOSE LEVEL WAS OVER 300 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS 120-150 MG/DL. PATIENT STATED, SHE TOOK CORRECTION VIA THE INFUSION DEVICE AND WAS ABLE TO GET HER BLOOD GLUCOSE UNDER CONTROL BY HERSELF. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPIDLINK INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEM INC. NA 32011680

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR INSULIN| INSULIN INFUSION PUMP