BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D LINK

    MDR report key: 2080269 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00860
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 9, 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 U.S. 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

    THE PT REPORTED 3 INFUSION SET HEADSETS LEAKED AROUND THE ADHESIVE AND THE CANNULA AND HIS BLOOD GLUCOSE ELEVATED TO 238-300 MG/DL. HE CHANGED THE HEADSET AND BOLUSED THROUGH THE INFUSION DEVICE. HIS NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. NO FURTHER INFO IS AVAILABLE. THE PT 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 EVAL.

    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 32153310

    Patients

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