BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1202728 · Received October 17, 2008

    Report

    Report Number
    2183996-2008-01575
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 3, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE ON TWO DAYS EARLIER. HE STATED THAT HIS BLOOD GLUCOSE MEASURED 232 MG/DL WHEN HE WOKE UP AND HE BOLUSED APPROXIMATELY 7 UNITS OF INSULIN. A FEW HOURS LATER, HIS BLOOD GLUCOSE MEASURED 300 MG/DL AND AT 11:00 AM HIS BLOOD GLUCOSE MEASURED 480 MG/DL AND HE BOLUSED 25.5 UNITS OF INSULIN. AFTER LUNCH, HIS BLOOD GLUCOSE MONITOR MEASURED "HI" (OVER 600 MG/DL) AND HE FELT "GROGGY." HE HAD MODERATE TO LARGE KETONES AND HE WENT TO THE EMERGENCY ROOM. AT THE HOSPITAL, THE PATIENT'S BLOOD GLUCOSE MEASURED 611 MG/DL AND HE WAS DISCONNECTED FROM THE INFUSION DEVICE AND TREATED WITH INSULIN INJECTIONS AND AN IV. SIX HOURS LATER, HE WAS ADMITTED TO INTENSIVE CARE AND HIS BLOOD GLUCOSE LOWERED TO NORMAL (80-140 MG/DL). HE WAS RELEASED FROM THE HOSPITAL ON THE NEXT DAY(PRIOR TO ORIGINAL DATE); HE STATED THAT HE BELIEVES HIS INFUSION SITE NEEDED TO BE CHANGED BECAUSE THE EDGES OF THE ADHESIVE WERE PEELING AND HE COULD SMELL INSULIN. THE INFUSION SITE HAD BEEN IN USE SINCE THE END OF THE PREVIOUS MONTH. HE CHANGES THE INFUSION SITE AND TUBING EVERY 2-3 DAYS. HE STATED THAT THE ADHESIVE OF HIS INFUSION SITE DO NOT ALWAYS SEEM TO BE AS "STICKY" AS THEY SHOULD BE. THE INFUSION SITE IN USE AT THE TIME OF THE EVENT WAS DISCARDED AT THE HOSPITAL. THE PATIENT IS CURRENTLY ON INJECTION THERAPY UNTIL HE MEETS WITH HIS PHYSICIAN. NO PRODUCT WILL 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R INSULIN| INSULIN INFUSION PUMP