BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2080261 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00851
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 8, 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
    MI, 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, THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE WHILE USING THE INFUSION SETS. UPON F/U ON (B)(6) 2011, THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 170-419 MG/DL DUE TO BENT INFUSION SET CANNULAS. HER NORMAL BLOOD GLUCOSE RANGE IS 70-140 MG/DL. SHE TREATED HERSELF BY INJECTING INSULIN VIA SYRINGE. SHE STATED SHE USED THE INSERTION DEVICE TO INSERT THE HEADSETS. THE INFUSION SETS DID NOT LEAK. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    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 48 YR INSULIN| INSULIN INFUSION PUMP