BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-D LINK

    MDR report key: 2110280 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01428
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, 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 OF 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

    PT REPORTED, THE INFUSION SET IS LEAKY ON THE FIX POINT FROM THE INFUSION SET NEEDLE. PT STATED, HE CHANGED THE INFUSION SET IMMEDIATELY. PT REPORTED, THERE WERE NO MEDICAL HEALTH EFFECTS. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP