BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1003225 · Received February 22, 2008

    Report

    Report Number
    2183996-2008-00196
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 11, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 02/11/2008, THE PATIENT REPORTED THAT THE CANNULAS OF HER INFUSION SETS ARE BENDING TO INSERTION INTO HER BODY. SHE STATED THAT SHE "JABS AND JABS AND IT DOES NOT INSERT." SHE STATED THE CANNULA "ACCORDIANS BACK." SHE STATED THAT SHE INSERTS THE HEADSET QUICKLY AND AT A 90 DEGREE ANGLE. SHE HAS 4 HEADSETS IN HER POSSESSION THAT SHE EXPERIENCED THIS ISSUE WITH. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED ADN 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 SYSTEMS, INC. NA 7D007UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN