BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFELX INFUSION SET

    MDR report key: 1252793 · Received December 4, 2008

    Report

    Report Number
    2183996-2008-01806
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    September 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT'S HUSBAND REPORTED THE PT HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE READINGS OF 300-500 MG/DL WITH HER RECOMMENDED RANGE BEING 80-150 MG/DL. HE SAID SHE WAS OFTEN UNABLE TO GO TO WORK WHEN HER READINGS WERE ELEVATED AND HER READINGS WOULD OFTEN DROP TO 70 MG/DL AFTER GIVING CORRECTION BOLUSES. HE STATED THE READINGS WERE CAUSED BY THE PT'S INFUSION SETS AS SHE FREQUENTLY FOUND THE CANNULA BENT WHEN SHE REMOVED THE HEADSET. HE SAID SHE INSERTED THE HEADSET BY HAND AND CHANGED HER INFUSION SET EVERY 3 DAYS. HE STATED SOME OF HER SITES HAVE BEEN INFECTED. HE STATED THE PT SWITCHED TO HER PREVIOUS INFUSION DEVICE WITH WHICH SHE USES AN INFUSION SET INSERTION DEVICE AND HER READINGS HAVE RETURNED TO NORMAL RANGE. THE PT DID NOT REQUIRE 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 ULTRAFELX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA 8A037UF

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R INSULIN| INSULIN INFUSION PUMP