BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 1945913 · Received December 28, 2010

    Report

    Report Number
    2183996-2010-02692
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 20, 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
    NL
    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 STARTING TO USE A NEW TYPE OF INFUSION SET AT THE BEGINNING OF (B)(6) 2010. PT STATED BEGINNING ON THE FIRST DAY OF USE; SHE STARTED GETTING IRRITATION AT THE INSERTION SITE. PT REPORTED FOR THE PAST WEEK THE PLASTER ON THE INFUSION SET IS WET. PT STATED SHE THINKS THE CONNECTION IS NOT GOOD. PT REPORTED HER BLOOD GLUCOSE LEVEL IS NORMAL. PT USES THE INSERTION ASSIST PLUS DEVICE TO INSERT THE INFUSION SETS. NO FURTHER INFO IS AVAILABLE. 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 FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX044

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET