BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081684 · Received April 13, 2011

    Report

    Report Number
    2183996-2011-01007
    Event Type
    Malfunction
    Date Received
    April 13, 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-1482-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THAT SHE EXPERIENCED ELEVATED BLOOD GLUCOSE OF UP TO 450 MG/DL DUE TO THE INFUSION SETS. TARGET BLOOD GLUCOSE IS 100-180 MG/DL. PATIENT DELIVERED INSULIN THROUGH A SYRINGE TO CORRECT HYPERGLYCEMIA. THERE WERE NO ISSUES WITH THE PREPARATION OR INSERTION OF THE INFUSION SET. THERE WAS NO INSULIN LEAKAGE. PATIENT DID NOT BELIEVE SHE WAS GETTING INSULIN WHILE USING THE INFUSION SETS. ONCE INFUSION CANNULA WAS BENT. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS. PATIENT USED A TOTAL OF 4 SAMPLE INFUSION SETS AND THEN SWITCHED TO A DIFFERENT TYPE. REQUEST WAS SUBMITTED FOR REPLACEMENT PRODUCT. ALLEGED PRODUCT WAS NOT AVAILABLE TO RETURN FOR EVALUATION. THE PATIENT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INSULIN| INSULIN INFUSION DEVICE