BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1063322 · Received June 19, 2008

    Report

    Report Number
    2183996-2008-00898
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT, WHILE AT AN APPOINTMENT WITH HIS NURSE EDUCATOR, HIS BLOOD GLUCOSE WAS ELEVATED TO 537 MG/DL. HIS NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. HE STATED THAT HE USES HIS INFUSION SITES FOR 6 DAYS TO SAVE MONEY. THE NURSE EDUCATOR ADVISED THE PT TO CHANGE THE INFUSION SITE EVERY 3 DAYS. THE NURSE ADVISED THE PT THAT USING THE INFUSION SITES FOR LONGER THAN RECOMMENDED COULD CAUSE ELEVATED BLOOD GLUCOSE AS WELL AS STRESS. THE PT CHANGED HIS INFUSION SITE AND BOLUSED 20 UNITS OF INSULIN TO LOWER HIS BLOOD GLUCOSE. TO TROUBLESHOOT THE PT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION SITE AND TO PRIME. INSULIN WAS DELIVERED PROPERLY. UPON FOLLOW UP IN 2008, THE PT REPORTED THAT HE WAS DOING WELL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INSULIN| INSULIN INFUSION SET