BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2011711 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00399
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    December 6, 2010
    Report Date
    February 16, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    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

    COMPANY REP REPORTED THE PT HAS HAD AN ABSCESS ON 2 OCCASIONS WHILE USING THE INFUSION SET. COMPANY REP STATED THE ISSUE OCCURRED ON (B)(6) 2010. COMPANY REP REPORTED PT WAS TREATED WITH PENICILLIN. ON CALL BACK, PT REPORTED AFTER USING THE INFUSION SET FOR A SHORT TIME, HE FELT A TINGLE, "BURNING" SENSATION AT THE INSERTION SITE AND NOTICED SWELLING IN THE AREA. PT STATED HE REMOVED THE INFUSION SET AND INSERTED A NEW INFUSION SET IN A DIFFERENT SITE WITH THE SAME ISSUE OCCURRING AFTER A SHORT TIME. PT REPORTED THE INFUSION SITE HAD A PURULENT BORDER AND THE DOCTOR OPENED THE AREA, HAD PT CHANGE THE DRESSING DAILY, AND PLACED HIM ON PENICILLIN. PT STATED HE IS USING A NEW BOX OF INFUSION SETS WITH A DIFFERENT LOT NUMBER AND HAS EXPERIENCED NO PROBLEMS. NO FURTHER INFO IS AVAILABLE. 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 0A112UF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION SET| INSULIN