BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1212733 · Received October 22, 2008

    Report

    Report Number
    2183996-2008-01613
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 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
    TX, 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 EXPERIENCING ISSUES WITH THE ADHESIVE OF HER INFUSION SITES STICKING TO HER BODY. SHE DID NOT HAVE TIME TO PROVIDE DETAILS. UPON FOLLOW UP ON (B) (6) 2008 AND (B) (6) 2008, THE PATIENT STATED THAT SHE WAS WORKING AND DID NOT HAVE TIME TO PROVIDE DETAILS. FURTHER ATTEMPTS TO FOLLOW UP WITH THE PATIENT WERE UNSUCCESSFUL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN