BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-D LINK INFUSION SET

    MDR report key: 2110286 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01440
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 26, 2010
    Report Date
    April 26, 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 THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED HE HAS BEEN EXPERIENCING A LEAKY INFUSION SET OVER AND UNDER THE SELF ADHESIVE FOR ONE YEAR. PT STATED HIS BLOOD GLUCOSE LEVELS BECAME ELEVATED UP TO 300 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE WAS NOT PROVIDED. PT REPORTED HE TOOK CORRECTION VIA THE INFUSION DEVICE AND WAS ABLE TO GET HIS BLOOD GLUCOSE UNDER CONTROL BY HIMSELF. PT STATED THE INFUSION SET OCCLUDED DURING PRIMING ON (B)(6) 2011. NO FURTHER INFO IS AVAILABLE. THE PT 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 EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID-D LINK INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 32365699

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR INSULIN| INSULIN INFUSION PUMP