BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID D INFUSION SET

    MDR report key: 898514 · Received August 15, 2007

    Report

    Report Number
    2183996-2007-01251
    Event Type
    Injury
    Date Received
    August 15, 2007
    Date of Event
    July 9, 2007
    Report Date
    August 7, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT IN 2007, HER BLOOD GLUCOSE WAS ELEVATED TO 295 MG/DL WHEN SHE WOKE UP. SHE BOLUSED THROUGH HER INFUSION DEVICE TO LOWER HER BLOOD GLUCOSE. SHE THEN RECEIVED AN E4 (OCCLUSION) WHILE AT WORK AND SHE DROVE HOME TO CHANGE HER INFUSION SET. SHE CORRECTED ELEVATED BLOOD GLUCOSE VIA INSULIN PEN. HER NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. THE PATIENT WAS UNSURE OF THE LOT NUMBER OF THE INFUSION SET IN USE AT THE TIME OF THE INCIDENT. SHE WILL RETURN 2 LOTS (411716 AND 232243). NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID D INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. RAPID D 411716

    Patients

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