BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1243168 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01709
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 3, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PATIENT REPORTED THAT 3 HEADSETS FROM HER CURRENT BOX OF INFUSION SETS HAVE OCCLUDED DURING USE AND ONE HAD A BENT CANNULA. THE HEADSETS WERE IN USE FOR 2 DAYS AT THE TIME OF OCCLUSION. SHE STATED THAT SHE CHANGES THE HEADSET EVERY 3-4 DAYS. SHE WAS ADVISED TO CHANGE THE HEADSET EVERY 3 DAYS. SHE USES HER LOWER ABDOMEN AS AN INFUSION SITE AND SHE STATED THAT AREA IS VERY SORE DURING INSERTION. SHE DOES NOT SEE ANY BLOOD OR SCAR TISSUE AT THE AREA. SHE BEGAN USING HEADSETS FROM ANOTHER LOT OF INFUSION SETS AND HAD NO FURTHER ISSUES. SHE ALSO MOVED HER INFUSION SITE FROM HER ABDOMEN TO HER HIP AREA. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PATIENT DISCARDED THE ALLEGED HEADSETS. PRODUCT WAS REPLACED. NO PRODUCT WILL 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 SYSTEMS NA 8F049UF

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR INSULIN| INSULIN INFUSION PUMP