BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1020634 · Received March 27, 2008

    Report

    Report Number
    2183996-2008-00405
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    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 Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT HER BLOOD GLUCOSE MEASURED 111 MG/DL WHEN SHE WOKE UP AND SHORTLY AFTER SHE BEGAN TO FEEL "FUNNY". HER BLOOD GLUCOSE HAD LOWERED TO 72 MG/DL. SHE TOOK ONE GLUCOSE TABLET AND DROVE TO WORK. WITHIN 1 HR THE PT'S BLOOD GLUCOSE ELEVATED TO 246 MG/DL AND 30 MINS AFTER THAT 250 MG/DL. SHE STATED THAT THERE WAS AN AREA ON HER INFUSION TUBING ? OF AN INCH LONG THAT APPEARED TO HAVE A CLOUDY AREA WITH SHINY LINES. SHE ATTEMPTED TO PRIME THE AREA FROM THE TUBING BUT IT DID NOT MOVE. THE INFUSION TUBING HAD NOT BEEN BENT OR KINKED. SHE PRIMED 8 UNITS OF INSULIN THROUGH THE INFUSION SET BEFORE INSULIN DRIPPED FORM THE END OF THE TUBING. SHE CHANGED THE INFUSION TUBING AND WAS ABLE TO PRIME SUCCESSFULLY. THE PT WAS DRINKING WATER, WALKING, AND BOLUSED TO LOWER HER BLOOD GLUCOSE. APPROX 45 MINS LATER THE PT'S BLOOD GLUCOSE BEGAN TO LOWER (223 MG/DL). HER NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED 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 NA 7J120UF

    Patients

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