BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2070364 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01092
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 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
    NY, 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 EXPERIENCING A BENT INFUSION SET CANNULA ON ONE OCCASION. PT STATED THE BENT INFUSION SET CANNULA CAUSED THE INFUSION SET TO PUNCTURE SIDEWAYS INTO HIS SKIN. PT REPORTED EXPERIENCING AN ELEVATED BLOOD GLUCOSE LEVEL UP TO THE 500'S MG/DL DUE TO THE ISSUE. PT'S NORMAL BLOOD GLUCOSE RANGE IS 200-300'S MG/DL. PT STATED HE TREATED HIMSELF BY BOLUSING. PT REPORTED THIS WOULD BRING HIS BLOOD GLUCOSE DOWN SHORTLY BUT WOULD GOT BACK UP. PT STATED HE CHANGED THE INFUSION SITE AND SAW THE INFUSION SET CANNULA WAS BENT. PT REPORTED NO ISSUES WITH PREPARATION OR INSERTION OF THE INFUSION SET. PT STATED THE INFUSION SITE DID NOT LEAK BUT IT MIGHT HAVE, HE IS NOT SURE. PT REPORTED NO ISSUES REMOVING THE INFUSION SITES. PT USED THE INSERTION ASSIST PLUS DEVICE TO INSERT THE INFUSION SETS. PT STATED HE NOTICED THE ISSUE WITHIN ONE DAY OF INSERTION OF THE INFUSION SET. PT REPORTED HE EXPERIENCED THE ISSUE ONLY ONE TIME. PT NO LONGER HAS 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 23 YR INSULIN| INSULIN INFUSION PUMP