BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1001368 · Received February 20, 2008

    Report

    Report Number
    2183996-2008-00190
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT THE HEADSET OF HER INFUSION SET BEGAN TO LEAK. HER INFUSION SITE IS IN HER ABDOMEN. SHE STATED THAT IT HAD BEEN IN PLACE FOR 3 DAYS. SHE STATED THAT DURING THOSE 3 DAYS HER ABDOMEN BECAME VERY LARGE AND TIGHT (THE PATIENT IS PREGNANT). SHE INSERTED A NEW HEADSET AND REPORTED THAT IT ALSO LEAKED INSULIN. SHE STATED THAT THE HEADSET DOES NOT APPEAR TO SIT FLUSH WITH HER ABDOMEN, AND SHE IS NO LONGER ABLE TO PINCH HER SKIN TO INSERT THE CANNULA. THE PATIENT WAS ADVISED OF ALTERNATIVE INFUSION SITES AND TO DISCUSS CHANGES WITH HER PHYSICIAN. UPON FOLLOW UP ON FIVE DAYS LATER, THE PATIENT REPORTED THAT SHE MOVED HER INFUSION SITE TO THE SIDE OF HER ABDOMEN AND HAS NO FURTHER ISSUES WITH LEAKS. 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 7H158UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP