BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1021482 · Received March 26, 2008

    Report

    Report Number
    2183996-2008-00389
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEM
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT THE INFUSION SITE SHE INSERTED THE AFTERNOON OF THE DAY BEFORE HAD ALREADY "COME LOOSE." SHE STATED THAT SHE USED AN INSERTION DEVICE FOR ASSISTANCE AND SHE USES IV PREP TO CLEANSE THE SELECTED AREA. SHE STATED THAT SHE DOES WAIT FOR THE AREA TO DRY BEFORE ADHERING THE INFUSION SITE TO HER SKIN. SHE ALSO USES SURGICAL TAPE TO KEEP THE INFUSION SITE IN PLACE. SHE STATED THAT THERE WAS A KINK IN THE CANNULA WHEN THE INFUSION SITE WAS REMOVED. HER BLOOD GLUCOSE WAS NOT AFFECTED. SHE WAS SENT A DIFFERENT TYPE OF DRESSING TO HELP KEEP THE INFUSION SITE IN PLACE. UPON FOLLOW UP ON THREE DAYS AFTER THE ORIGINAL DATE, THE PT STATED THAT HER INFUSION SITES ARE STICKING BETTER WITH THE DRESSING. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEM NA 7K185UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP