BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1163067 · Received September 15, 2008

    Report

    Report Number
    2183996-2008-01422
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 2, 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
    NY, 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 EXPERIENCING ELEVATED BLOOD GLUCOSE WITH KETONES FOR 4-5 DAYS. HE STATED THAT HE MUST CHANGE HIS INFUSION SET EVERY 2.5 DAYS OR HIS BLOOD GLUCOSE BEGINS TO ELEVATE. HE STATED THAT HE CHANGED HIS INFUSION SET ON THE PREVIOUS MONTH, AND ON THE NEXT DAY, HIS BLOOD GLUCOSE WAS ELEVATED TO 236 MG/DL. HIS BLOOD GLUCOSE DECREASED BUT ELEVATED TO 188 MG/DL AFTER EATING. HE BOLUSED AND AFTER 1 HOUR HIS BLOOD GLUCOSE HAD NOT DECREASED AND HE CHANGED HIS INFUSION SITE. ON THREE DAYS LATER, HIS BLOOD GLUCOSE ELEVATED TO 310 MG/DL AND HE TESTED POSITIVE FOR KETONES IN HIS URINE AND HE CHANGED HIS INFUSION SET. ON THE DAY PRIOR TO ORIGINAL DATE, HIS BLOOD GLUCOSE MEASURED 318 MG/DL AT 1:00 AM AND HE BOLUSED 1.5 UNITS OF INSULIN. ONE HOUR LATER HIS BLOOD GLUCOSE MEASURED 311 MG/DL AND HIS URINE TESTED POSITIVE FOR KETONES. HE STATED THAT HE HAS USED HIS ABDOMEN AS AN INFUSION SITE SINCE 2001. HE STATED THAT HE PRACTICES PROPER SITE ROTATION AND DOES NOT HAVE ANY HARDENED TISSUE. THE PT WAS SENT SAMPLE INFUSION SETS. UPON FOLLOW UP ON SIX DAYS AFTER THE ORIGINAL DATE, THE PT STATED THAT HE TRIED THE NEW PRODUCTS ON TWO DAYS AFTER THE ORIGINAL DATE, AND EXPERIENCED ELEVATED BLOOD GLUCOSE ON THE NEXT DAY. HE MOVED HIS INFUSION SITE SEVERAL INCHES AWAY FROM HIS NORMAL AREA AND HIS BLOOD GLUCOSE RETURNED TO NORMAL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OF 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 8A232UF

    Patients

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