BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070414 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01115
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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, THE PATIENT REPORTED EXPERIENCING BENT INFUSION SET CANNULAS, ELEVATED BLOOD GLUCOSE, AND SKIN IRRITATION WHILE USING THE INFUSION SETS. HIS BLOOD GLUCOSE ELEVATED TO 290 MG/DL. HIS NORMAL BLOOD GLUCOSE RANGE IS 120-130 MG/DL. HE TREATED ELEVATED BLOOD GLUCOSE BY BOLUSING THROUGH THE INFUSION DEVICE. HE NOTICED THE BENT CANNULA WHEN THE HEADSET WAS REMOVED. HE STATED AN E4 (OCCLUSION) ERROR WAS DISPLAYED ON THE INFUSION DEVICE AT THAT TIME. HE WASHED THE IRRITATED AREA WITH SOAP AND WATER. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED PRODUCT WAS DISCARDED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 55 YR INSULIN| INSULIN INFUSION PUMP