BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1014068 · Received March 13, 2008

    Report

    Report Number
    2183996-2008-00343
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 7, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HE HAD EXPERIENCED OCCLUSION ERRORS (COMPETITOR INFUSION DEVICE) WITH 4 INFUSION SETS IN THE PAST 2 WEEKS. HE STATED THAT THE OCCLUSION WOULD OCCUR DURING THE FIRST BOLUS AFTER THE INFUSION SITE WAS INSERTED. HE WOULD IMMEDIATELY REMOVE THE INFUSION SITE AND FOUND THAT EACH CANNULA WAS SLIGHTLY BENT. HE STATED HE USES A 4 INCH AREA ON EACH SIDE OF HIS ABDOMEN AS AN INFUSION SITE AND HE ROTATES FROM SIDE TO SIDE. HE STATED, HE HAS USED THIS SAME AREA FOR 4.5 YRS. HE WAS EDUCATED ON INFUSION SITE ROTATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 7H155UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP