BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2031463 · Received March 18, 2011

    Report

    Report Number
    2183996-2011-00555
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1487-2011
    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 EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED ELEVATED BLOOD GLUCOSE DUE TO BENT INFUSION CANNULAS. INFUSION HEADSETS WERE INSERTED BY HAND, AND THIS WAS FIRST NOTICED ON (B)(6) 2011 WHEN BLOOD GLUCOSE ELEVATED TO THE 400 MG/DL RANGE. NO ERROR MESSAGES WERE DISPLAYED ON THE INFUSION DEVICE. PT REMOVED THE HEADSET AND NOTICED THE CANNULA WAS BENT. HE INSERTED A NEW HEADSET BUT BLOOD GLUCOSE REMAINED ELEVATED. HE TREATED HYPERGLYCEMIA WITH INJECTION THERAPY. PT WAS STILL USING THE INFUSION DEVICE BUT BELIEVED HE WAS NOT GETTING ENOUGH INSULIN DUE TO THE ONGOING ISSUE OF BENT INFUSION CANNULAS. HE EXPERIENCED BENT CANNULAS WITH 6-8 INFUSION SETS. THE ALLEGED PRODUCT WAS DISCARDED AND NOT REQUESTED FOR EVAL. PT WAS SENT 2 DIFFERENT TYPES OF INFUSION SETS TO TRY. FOLLOW-UP WAS COMPLETED WITH HIM ON (B)(4) 2011. PT REPORTED "EVERYTHING IS WORKING FINE" SINCE STARTING A NEW TYPE OF INFUSION SET. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE 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 FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX042

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR INSULIN| INSULIN INFUSION DEVICE