BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081493 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00986
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 15, 2011
    Report Date
    March 15, 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, PT REPORTED THAT HE EXPERIENCED CONCERNS WITH 2 OF THE 4 INFUSION SETS THAT HE USED. A COUPLE OF MONTHS AGO, PT MANUALLY INSERTED A HEADSET IN A QUICK, STRAIGHT MOTION. BLOOD GLUCOSE ELEVATED "PRETTY (B)(6) HIGH" 10-12 HOURS LATER. TARGET BLOOD GLUCOSE IS 100 MG/DL. PT REMOVED THE HEADSET AND NOTICED THE CANNULA WAS BENT IN 2 SPOTS. THERE WAS ALSO INSULIN LEAKAGE AT HIS INFUSION SITE. PT INSERTED A DIFFERENT TYPE OF INFUSION SET, AND HIS BLOOD GLUCOSE DECREASED TO HIS NORMAL RANGE. DURING THE SECOND EVENT, PT NOTICED IT WAS DIFFICULT FOR THE INTRODUCER NEEDLE TO PIERCE HIS SKIN. PT HAD TO USE MORE FORCE THAN USUAL. PT USED THIS TYPE OF INFUSION SET FOR A TOTAL OF 12-14 DAYS. ALLEGED INFUSION SETS WERE DISCARDED AND WILL NOT BE RETURNED FOR EVAL. REQUEST WAS SUBMITTED FOR REPLACEMENT PRODUCT. THE PT 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 26 YR INSULIN| INSULIN INFUSION DEVICE