BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2070395 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01080
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    December 1, 2010
    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
    AR, 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'S CAREGIVER REPORTED HIS INFUSION SETS WOULD NOT STAY ATTACHED TO THE SKIN, INSULIN LEAKED FROM THE INFUSION SET AND THE INFUSION SET CANNULA KINKED LEADING TO ELEVATED BLOOD GLUCOSE LEVELS. PATIENT'S CAREGIVER STATED NOTHING ABNORMAL OCCURRED DURING PREPARATION OR INSERTION. PATIENT INSERTS THE INFUSION SETS MANUALLY AND WITH THE INSERTION ASSIST PLUS DEVICE. CAREGIVER REPORTED THE ISSUE OCCURRED MORE THAN ONCE BUT THEY ARE UNSURE HOW MANY TIMES. CAREGIVER STATED THE INFUSION SET LEAKED INSULIN, THE INFUSION SET CANNULA WAS BENT AND THE PATIENT'S BLOOD GLUCOSE READINGS WOULD GO UP TO THE 270S MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 160-170 MG/DL. CAREGIVER REPORTED THE PATIENT CHANGED THE INFUSION SET AND USED THE INFUSION DEVICE TO CORRECT HIS ELEVATED BLOOD GLUCOSE. CAREGIVER STATED THE ISSUES WERE NOTICED WITHIN 2-3 HOURS AFTER INSERTION. CAREGIVER REPORTED THE ISSUE BEGAN WHEN PATIENT STARTED USING THE INFUSION SET IN (B)(6) 2010 OR (B)(6) 2011. PATIENT DISCARDED THE ALLEGED INFUSION SETS. 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 GWX113

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INSULIN| INSULIN INFUSION PUMP