BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 1000992 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00168
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 5, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT REPORTED, ELEVATED BLOOD GLUCOSE READINGS AVERAGING 245 MG/DL OVER THE PAST 2 WEEKS. HE STATED, HIS MOST RECENT ELEVATED BLOOD GLUCOSE READING WAS LAST NIGHT AT 395 MG/DL WITH HIS TARGET RANGE BEING 90-300 MG/DL. HE STATED, HIS SYMPTOMS WERE FATIGUE, THIRST, AND ARTHRITIS AND HE CORRECTS HIS READING BY BOLUSING INSULIN BY INJECTION. HE STATED, HE IS A "BRITTLE DIABETIC." DURING TROUBLESHOOTING, THE PT STATED, HE USUALLY CHANGES HIS INSULIN EVERY 10-30 DAYS DEPENDING ON USE. HE SAID, HE USES HIS HEAD SET "UNTIL INTERRUPTION" AND REPORTS AN AVERAGE USE OF 1 WEEK OR LONGER. HE STATED, HE HAS ONLY USED THE SITE BELOW HIS NAVEL SINCE HE BEGAN PUMP THERAPY IN 2002. THE PT STATED, HE STORES HIS INSULIN IN THE REFRIGERATOR UNTIL THE VIAL IS OPENED AND THEN STORES THE VIAL IN HIS INFUSION DEVICE CASE. HE STATED, HE BEGAN EATING A HEALTHIER DIET AND EXERCISING 2 MONTHS AGO AND HAS LOST 10 POUNDS. THE PT WAS EDUCATED ON SITE SELECTION AND ROTATION. THE PT WAS ADVISED TO CHANGE ACCESSORIES AS RECOMMENDED WHICH IS 2-3 DAYS FOR INFUSION SETS AND EVERY 6 DAYS FOR INSULIN CARTRIDGES. TROUBLESHOOTING DID NOT FINE PRODUCT ISSUES. AN INSERTION AIDE AND A GUIDE TO INFUSION SITE MGMT WAS SENT TO THE PT. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

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