BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081480 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00981
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1488-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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, CLINICAL TRAINER REPORTED THAT PT EXPERIENCED INSULIN LEAKAGE FROM THE INFUSION SET. F/U WAS COMPLETED WITH PT, AND SHE REPORTED HER INFUSION SET HAD BEEN LEAKING SINCE THAT MORNING. BLOOD GLUCOSE ELEVATED TO 500 MG/DL, AND NORMAL BLOOD GLUCOSE IS 100-200 MG/DL. PT DRANK WATER TO TREAT HYPERGLYCEMIA. PT REPORTED, THE HEADSET DID NOT FULLY INSERT WHEN SHE USED THE INSERTION DEVICE, AND SHE PRESSED IT THE REST OF THE WAY IN WITH HER FINGER. SHE DID NOT NOTICE ANY BENDS OR KINKS OF THE CANNULA. PT USED THE HEADSET FOR 1 DAY BEFORE THE INSULIN LEAKAGE OCCURRED. THIS WAS THE FIRST TIME SHE EXPERIENCED CONCERNS WITH THE INFUSION SETS SINCE STARTING THEM 2 WEEKS AGO. NO PRODUCT WAS REQUESTED FOR EVAL. PRODUCT WAS REPLACED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 GWX121

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR INSULIN INFUSION DEVICE| INSULIN