BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2070398 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01082
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS IN THE 300'S MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 60-120 MG/DL. PATIENT STATED HE INJECTED BY SYRINGE TO REDUCE HIS BLOOD GLUCOSE LEVEL AND CHANGED THE INFUSION SET. PATIENT REPORTED HE NEVER NOTICED THE INFUSION SET CANNULA BEING BENT OR DAMAGED. PATIENT REPORTED ONE INCIDENT WHERE INSULIN LEAKED AT THE INFUSION HEADSET. PATIENT STATED HE NOTICED BECAUSE HIS SHIRT WAS WET. PATIENT REPORTED THERE WAS NO BLOOD AT THE INFUSION SITE. PATIENT USED THE INSERTION ASSIST PLUS DEVICE TO INSERT THE INFUSION SETS THE MAJORITY OF THE TIME. REVIEWED INSERTION SITE ROTATION. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR INSULIN INFUSION PUMP| INSULIN