BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D LINK

    MDR report key: 2781903 · Received October 5, 2012

    Report

    Report Number
    2183996-2012-01509
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 1, 2011
    Report Date
    September 18, 2012
    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
    NOT APPLICABLE

    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 THE INFUSION SET HAS LEAKED INSULIN BETWEEN THE CANNULA AND SELF-ADHESIVE SEVERAL TIMES SINCE (B)(6) 2011. HIS BLOOD GLUCOSE HAS ELEVATED AS HIGH AS 300 MG/DL AS A RESULT. HE CHANGES THE INFUSION SET AND DELIVERS INSULIN VIA THE INFUSION DEVICE AS TREATMENT FOR HYPERGLYCEMIA. THE CARTRIDGE IS CHANGED IN EVERY 3 DAYS AND THE INFUSION SET IS CHANGED EVERY 2-3 DAYS. HE HAS NOT HAD A INFECTION OR STARTED NEW MEDICATION. THE INFUSION SET WAS REQUESTED FOR EVALUATION. HE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PART TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D LINK FPA ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006930 32372141

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR INSULIN INFUSION PUMP| ACCESSORIES| INSULIN