BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D

    MDR report key: 2081531 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00962
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THERE WAS BLOOD AND INSULIN ON THE INFUSION SET ADHESIVE. PT CHANGED THE INFUSION NEEDLE AND WAS ABLE TO SMELL INSULIN. INFUSION SITES ARE ROTATED CORRECTLY, AND THE INFUSION SITE WAS NOT BUMPED OR HIT. THERE WAS NO SCAR TISSUE IN THE AREA. INFUSION SET WAS IN USE FOR 2 DAYS. ALLEGED INFUSION SET WAS DISCARDED, AND WILL NOT BE RETURNED FOR EVAL. THE PT DID NOT REQUIRE ASSISTANCE 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 RAPID D INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 32354250

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR INSULIN INFUSION DEVICE| INSULIN