BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1052847 · Received May 27, 2008

    Report

    Report Number
    2183996-2008-00773
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 19, 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
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE HAS NOTICED LEAKING AND BLOOD ON THE ADHESIVE OF HER INFUSION SITES. THE PT STATED THAT SHE DOES NOT NOTICE SCAR TISSUE OR BUMPS. SHE USES IV PREP WIPES PRIOR TO INSERTING THE INFUSION SITE. SHE PRACTICES PROPER INFUSION SITE ROTATION. SHE REPORTED THAT SHE RECENTLY LOST WEIGHT. SHE USES THE 8MM CANNULA LENGTH. SHE WAS SENT SAMPLES OF INFUSION SETS WITH A 10MM CANNULA LENGTH. UPON FOLLOW UP TWO DAYS LATER, THE PT REPORTED THAT SHE BEGAN USE OF THE 10MM CANNULAS AND HAS HAD NO FURTHER ISSUES. NO BLOOD GLUCOSE ISSUES WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD WILL 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP