BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2071807 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01153
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, HUSBAND REPORTED THAT PT EXPERIENCED CELLULITIS DUE TO THE INFUSION SET. THE HEADSET WAS INSERTED IN THE MORNING, AND BY THE AFTERNOON, THE INFUSION SITE WAS RED AND PAINFUL. PT SAW HER PHYSICIAN THE NEXT DAY AND WAS DIAGNOSED WITH CELLULITIS. PT WAS ALSO TAKEN OFF OF THE INFUSION DEVICE. THIS OCCURRED APPROX 2 MONTHS PRIOR TO THE REPORT. INFUSION SITE WAS LOCATED ON PT'S ABDOMEN. THERE WAS NO INSULIN LEAKAGE, AND THE INFUSION CANNULA WAS NOT BENT. PT DID NOT EXPERIENCE ANY BLOOD GLUCOSE CONCERNS AS A RESULT. PRODUCT WAS REPLACED. ALLEGED PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL. F/U WAS COMPLETED WITH PT ON (B)(6) 2011. PT REPORTED THAT SHE WAS TREATED WITH ANTIBIOTICS AND THAT "EVERYTHING IS OKAY." PHYSICIAN HAS NOT GIVEN APPROVAL FOR PT TO RESTART INFUSION DEVICE THERAPY AS HE WANTS TO BE CERTAIN THE CELLULITIS HAS RESOLVED. NO ADD'L CONCERNS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA GWX150

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention INSULIN INFUSION DEVICE| INSULIN