BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1192523 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01525
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 25, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REPORTED THAT ON THREE DAYS EARLIER, SHE WAS FEELING NAUSEOUS AND NOT "RIGHT". SHE SAID SHE WENT TO THE HOSP WHERE HER BLOOD GLUCOSE READING WAS OVER 300 MG/DL, AND SHE WAS DIAGNOSED WITH KETOACIDOSIS. SHE STATED SHE WAS GIVEN AN INJECTION OF INSULIN AND WITHIN 1 1/2 HRS, HER READING DECREASED (NO VALUE PROVIDED). SHE SAID SHE WAS RELEASED FROM THE HOSPITAL ON THE NEXT DAY. SHE STATED WHEN SHE REMOVED HER INSULIN INFUSION HEADSET, THE CANNULA WAS KINKED AND IT HADN'T "EVEN GONE THROUGH THE SKIN". SHE STATED THE HEADSET HAD BEEN IN USED FOR 1 DAY AND SHE DID NOT RETAIN THE HEADSET. THE PT WAS SENT A COMPLIMENTARY INSERTION DEVICE AND REPLACEMENT INFUSION SETS. NO PROD WAS AVAILABLE TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INUSLIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 8F021UF

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INSULIN INFUSION PUMP| INSULIN