BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPIDLINK INFUSION SET

    MDR report key: 1941047 · Received December 8, 2010

    Report

    Report Number
    2183996-2010-02561
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 THAT AFTER INSERTING THE INFUSION SET ON HIS INFUSION DEVICE, THE INFUSION BEGAN AND THEN AFTER A FEW HOURS, THE PT REALIZED THAT THE INSULIN WAS LEAKING AT THE LEVEL OF THE INFUSION SET ABOVE THE NEEDLE, ON THE PLASTER. PT REPORTED HAVING TO TRY AGAIN 7 TIMES BEFORE SUCCEEDING. 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 EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPIDLINK INFUSION SET INSULIN INFUSION SET LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA 32061710

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR INSULIN INFUSION SET| INSULIN