BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2051382 · Received April 4, 2011

    Report

    Report Number
    2183996-2011-00790
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, WIFE REPORTED THAT PT HAS EXPERIENCED ELEVATED BLOOD GLUCOSE IN THE 250-300 MG/DL RANGE SINCE STARTING A NEW TYPE OF INFUSION SET. PT BOLUSED AS A CORRECTION FOR HYPERGLYCEMIA. NORMAL BLOOD GLUCOSE WAS NOT PROVIDED, BUT WIFE SAID, IT IS LOWER THAN THE READINGS HE EXPERIENCED. PT ALSO EXPERIENCED A CONCERN WITH THE INFUSION CANNULAS BENDING. THERE WERE NO ISSUES WITH THE PREPARATION OR INSERTION OF THE INFUSION SET, AND THE INFUSION SITES DID NOT LEAK INSULIN. THERE WERE NO ISSUES REMOVING THE INFUSION HEADSETS. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS. PT NOTICED THE CONCERN "INSTANTLY" AFTER THE HEADSET WAS INSERTED. NO PRODUCT WAS REQUESTED FOR EVAL. REPLACEMENT PRODUCT WAS SENT. THE PT DID NOT REQUIRE TREATMENT 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 GWX175

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR INSULIN INFUSION DEVICE| INSULIN