BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 1100816 · Received August 6, 2008

    Report

    Report Number
    2183996-2008-01171
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 31, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT STATED THAT SHE CHANGED HER INFUSION SITE IN 2008 AT 8:00PM. ON THE NEXT DAY, THE PATIENT WENT SWIMMING FROM 8:00-9:00AM AND THE INFUSION SET FELL OFF HER BODY. HER BLOOD GLUCOSE ELEVATED TO 400 MG/DL. SHE INJECTED INSULIN VIA PEN. HER NORMAL BLOOD GLUCOSE LEVEL IS 100-120 MG/DL. THE PATIENT ALSO REPORTED THE INFUSION SETS FALL OFF OF HER BODY WHILE SHOWERING. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 8C043UF

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention INSULIN| INSULIN INFUSION PUMP