BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2062514 · Received April 7, 2011

    Report

    Report Number
    2183996-2011-00863
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1487-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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, PT REPORTED THAT HE REC'D TREATMENT AT THE HOSPITAL 2 DIFFERENT TIMES DUE TO HYPERGLYCEMIA THAT WAS CAUSED BY BENT INFUSION CANNULAS. THE FIRST TIME HE WENT TO THE HOSPITAL WAS ON (B)(6) 2011, AND HE WAS DISCHARGED ON (B)(6) 2011. PT HAD BEEN THROWING UP AND HAD BLOOD GLUCOSE FROM 400-500'S MG/DL. PT WAS TREATED WITH AN INSULIN DRIP. THEN, ON (B)(6) 2011, PT THREW UP AGAIN AND HAD BLOOD GLUCOSE FROM 400-500'S MG/DL. HIS DAUGHTER TRANSPORTED HIM TO THE EMERGENCY ROOM. HE WAS ADMITTED TO THE HOSPITAL AND DISCHARGED ON (B)(6) 2011, AND HE WAS TREATED WITH AN INSULIN DRIP. PT WAS ADVISED TO NOT USE THE INFUSION DEVICE FOLLOWING THIS. NORMAL BLOOD GLUCOSE IS APPROX 200 MG/DL. NO ERROR MESSAGES WERE REC'D ON THE INFUSION DEVICE. THERE WERE NO ISSUES WITH THE PREPARATION, INSERTION, OR REMOVAL OF THE INFUSION SET. THERE WAS NO INSULIN LEAKAGE. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS. PT NOTICED THIS ISSUE ABOUT 1 DAY AFTER THE HEADSET WAS INSERTED. NO PRODUCT WILL BE RETURNED FOR EVAL. PRODUCT WAS REPLACED.

    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 GWX192

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R INSULIN (DATE OF (B)(6))| (DATE OF TX (B)(6))| INSULIN INFUSION DEVICE