BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-D LINK INFUSION SET

    MDR report key: 2170891 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01901
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 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 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 FOR MANY WEEKS HE USES THE INFUSION SETS. PT STATED, SOMETIMES THE INFUSION SETS ARE LEAKY AT THE CONNECTOR. PT REPORTED RECEIVING ELEVATED BLOOD GLUCOSE LEVEL OF MORE THAN 300 MG/DL. PT'S NORMAL BLOOD GLUCOSE IS APPROX 130 MG/DL. PT STATED, HE TOOK CORRECTION VIA THE INFUSION DEVICE AFTER CHANGING THE INFUSION SET. NO FURTHER INFO 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 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 32084610

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR INSULIN INFUSION PUMP| INSULIN