BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 1900236 · Received November 10, 2010

    Report

    Report Number
    2183996-2010-02281
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE U.S. 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

    ON (B)(6) 2010 AT 1:00 PM, PT CHANGED THE INFUSION SET. ON (B)(6) 2010 AT 12:01 PM, BLOOD GLUCOSE WAS 140 MG/DL. AT 7:30 PM, BLOOD GLUCOSE WAS 240 MG/DL. PT ATE AND ADMINISTERED INSULIN THROUGH INFUSION DEVICE. AT 10:39 PM, BLOOD GLUCOSE WAS 210 MG/DL. PT ADMINISTERED ADDITIONAL INSULIN THROUGH INFUSION DEVICE AT 10:39 AND 10:50 PM. AT 11:18 PM, BLOOD GLUCOSE WAS 431 MG/DL. PT CHECKED THE INFUSION SET AND NOTICED THE SELF-ADHESIVE PATCH WAS WET AND INSULIN APPEARED TO BE LEAKING. PT CHANGED THE INFUSION HEADSET. ON (B)(6) 2010 AT 9:55 AM, BLOOD GLUCOSE WAS 121 MG/DL. PT DOES NOT REUSE THE INSULIN CARTRIDGE AND CHANGES IT EVERY 4-7 DAYS. INFUSION HEADSET IS CHANGED EVERY 2 DAYS. PT HAD THE FLU AND AN INFECTION. PT DID NOT LOSE CONSCIOUSNESS OR REQUIRE HOSPITALIZATION. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFO WAS AVAILABLE.

    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 GWX021

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention INSULIN| INFUSION DEVICE