BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2012487 · Received February 9, 2011

    Report

    Report Number
    2183996-2011-00171
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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

    THE PT REPORTED THE INFUSION SET LEAKS INSULIN AT THE CONNECTION TO THE HEADSET. DUE TO INSULIN LEAKAGE, THE PT EXPERIENCED EVALUATED BLOOD GLUCOSE OF 42 MMOL/L (756 MG/DL) DESPITE CHANGING THE INFUSION SET SEVERAL TIMES AND BOLUSING THROUGH THE INFUSION DEVICE. THE PT WAS HOSPITALIZED ON (B)(6) 2010 AND WAS RELEASED ON (B)(6) 2010. THE PT'S NORMAL BLOOD GLUCOSE RANGE IS 4-12 MMOL/L (72-216 MG/DL). NO FURTHER INFO IS AVAILABLE. THE INFUSION SET WAS REQUESTED 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 GWX120

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R (DATE OF TX, (B)(6))| INSULIN (DATE OF TX, (B)(6))| INSULIN INFUSION PUMP