BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1063341 · Received June 19, 2008

    Report

    Report Number
    2183996-2008-00899
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 14, 2008
    Report Date
    June 16, 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
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 06/16/2008 THE PT REPORTED THAT SHE WENT TO BED ON THREE DAYS EARLIER WITH A BLOOD GLUCOSE LEVEL OF 112 MG/DL AND AT 6AM THE FOLLOWING MORNING SHE WOKE UP RESTLESS AND THIRSTY. HER INFUSION SET HEADSET HAD FALLEN OFF OF HER BODY DURING THE NIGHT AND HER BLOOD GLUCOSE WAS ELEVATED TO 284 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 80-150 MG/DL. THE HEADSET HAD BEEN IN USE FOR 2.5 DAYS. THE PT INSERTED A NEW HEADSET AND USED TEGADERM TO KEEP IT IN PLACE AND BOLUSED 3.5 UNITS OF INSULIN TO LOWER HER BLOOD GLUCOSE. BY 1 PM THE PT'S BLOOD GLUCOSE HAD RETURNED TO NORMAL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND 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 NA 8A033UF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION PUMP