BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2112640 · Received April 28, 2011

    Report

    Report Number
    2183996-2011-01282
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 6, 2011
    Report Date
    April 6, 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
    MO, 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 ONE TIME WHEN SHE INSERTED THE INTRODUCER NEEDLE INTO HER BODY, SHE NOTICED THAT IT HURT. PT STATED SHE REMOVED THE INFUSION SET CANNULA FROM HER BODY AND IT WAS BENT. PT MANUALLY INSERTED THE INFUSION SET. PT REPORTED SHE DID NOT NOTICE ANY ISSUES DURING INSERTION AND NO LEAKING AT THE INFUSION SITE. PT STATED THERE WAS NO DEVIATION IN HER BLOOD GLUCOSE LEVEL. PT REPORTED SHE NOTICED THE ISSUE IMMEDIATELY. PT STATED SHE NOTICED THIS ISSUE ONE TIME AND THE INFUSION SET CANNULA WAS BENT IN ONE LOCATION AT THE ADHESIVE. PT DISCARDED THE ALLEGED INFUSION SET. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 61 YR INSULIN INFUSION PUMP| INSULIN