BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1052801 · Received May 27, 2008

    Report

    Report Number
    2183996-2008-00771
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 265 MG/DL WITH HER NORMAL RANGE BEING 65-120 MG/DL. SHE STATED HER SYMPTOM WAS NAUSEA AND SHE CORRECTED HER READING BY RUNNING A BOLUS OF INSULIN. THE PT STATED SHE IS NEW TO INSULIN PUMP THERAPY. DURING TROUBLESHOOTING, SHE STATED SHE NOTICED SOME BLEEDING WHEN SHE INITIALLY INSERTS HER INSULIN INFUSION HEADSET. SHE SAID SHE DISCARDED THE HEADSET AT ISSUE. SHE STATED THE INFUSION SET CANNULA WAS BENT IN AN "L" SHAPE WHEN SHE TOOK IT OUT. SHE STATED SHE CONSULTED WITH HER PHYSICIAN ABOUT INSULIN ADJUSTMENTS AND HE INCREASED HER HOURLY BASAL RATES. A COMPLIMENTARY INSERTION AID DEVICE, GUIDE TO SITE MANAGEMENT AND REPLACEMENT INFUSION SETS WERE SENT TO THE PT. ON FOLLOW UP, THE PT STATED SHE IS USING THE INSERTION AID DEVICE AND HER BLOOD GLUCOSE READINGS ARE STILL ELEVATED UP TO 400 MG/DL. SHE STATED SHE CORRECTED THIS BY RUNNING A BOLUS. AN INFUSION SET WITH A LONGER CANNULA WAS SENT TO THE PT. ON FURTHER FOLLOW UP, THE PT STATED SHE BELIEVES ONE OF THE MEDICINES SHE IS ON IS CAUSING HER ELEVATED GLUCOSE. THE PRODUCT WAS REPLACED. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA 7K193UF

    Patients

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