BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2002958 · Received February 8, 2011

    Report

    Report Number
    2183996-2011-00162
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    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. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT REPORTED THE INFUSION SET LEAKS INSULIN BETWEEN THE NEEDLE AND THE TUBING. THE PT EXPERIENCED ELEVATED BLOOD GLUCOSE OF 415 MG/DL. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR OTHER PARTY TO ADDRESS THE ISSUE. THE INFUSION SET IS NOT AVAILABLE TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP