BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEX LINK INFUSION SET

    MDR report key: 1833148 · Received September 9, 2010

    Report

    Report Number
    2183996-2010-01865
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 31, 2010
    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
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED TWO OF HIS INFUSION SETS ARE BROKEN. PATIENT STATED THE 1ST ONE BROKE OFF AT THE INFUSION DEVICE END. PATIENT REPORTED THE 2ND INFUSION SET WAS LEAKING AND HE WAS UNAWARE UNTIL HE CHECKED HIS BLOOD GLUCOSE. PATIENT STATED HE HAD 3 BOXES OF INFUSION SETS WITH THE SAME LOT NUMBER. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PATIENT RETURNED ALL 3 UNUSED BOXES OF INFUSION SETS AND ONE USED INFUSION SET FOR EVALUATION; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEX LINK INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 7490102

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET