BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1346695 · Received March 17, 2009

    Report

    Report Number
    2183996-2009-00376
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 9, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2009, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 14-19 MMOL/L (252-342 MG/DL) FOR THE PAST WEEK. HER TARGET BLOOD GLUCOSE RANGE IS 6.5-7.0 MMOL/L (117-126 MG/DL). TODAY HER BLOOD GLUCOSE ELEVATED TO 26 MMOL/L (468 MG/DL) AND SHE CHANGED HER INFUSION SET. SHE STATED THAT THE CANNULA OF THE INFUSION SITE WAS BENT "AT AN ANGLE LIKE AN L." SHE STATED THAT THE INFUSION SITE WAS PLACED IN 2009 AND "ALL DAY HER SUGARS WERE GREAT". SHE STATED THAT SHE RECENTLY SWITCHED INFUSION SITES FROM HER STOMACH TO THE "SIDE TOWARDS THE BUTTOCKS AREA" DUE TO INFUSION ABSORPTION ISSUES. TO LOWER HER BLOOD GLUCOSE SHE BOLUSED 5 UNITS O F INSULIN AND DRANK 2 GLASSES OF WATER. THE PATIENT CALLED BACK IN THE NEXT DAY TO REPORT HER BLOOD GLUCOSE HAD LOWERED TO 20 MMOL/L (360 MG/DL). SHE WAS SENT SAMPLE INFUSION SETS AND AN INFUSION SET INSERTION DEVICE. A REQUEST FOR ADDITIONAL TRAINING WAS SUBMITTED. UPON FOLLOW UP IN THE NEXT DAY, THE PATIENT STATED THAT HER BLOOD GLUCOSE WAS STILL ELEVATED. SHE STATED THAT SHE CHANGES HER INSULIN CARTRIDGE AND INFUSION SET EVERY 10 DAYS. SHE WAS ADVISED TO CHANGE THE INSULIN CARTRIDGE AND INFUSION TUBING EVERY 6 DAYS AND THE INFUSION SITE EVERY 3 DAYS. THE PATIENT REPORTED THAT LAST NIGHT HER BLOOD GLUCOSE BEGAN TO ELEVATE AGAIN AND SHE "TOOK A LOT OF INSULIN." THIS MORNING HER BLOOD GLUCOSE MEASURED 15-16 MMOL/L (270-288 MG/DL) AND SHE STATED "I DO FEEL BETTER". THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    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 7J247UF

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention INSULIN INFUSION PUMP| INSULIN