BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1132010 · Received August 19, 2008

    Report

    Report Number
    2183996-2008-01252
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 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
    CO, 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 THAT HIS BLOOD GLUCOSE WAS ELEVATED TO 291 MG/DL THIS MORNING AND MEASURED 290 MG/DL AT LUNCHTIME. HIS BLOOD GLUCOSE AT THE TIME OF THE REPORT WAS 341 MG/DL. HE DID NOT KNOW HIS TARGET BLOOD GLUCOSE RANGE. HE STATED THAT YESTERDAY HE BOLUSED AND HIS PANTS BECAME WET BECAUSE HIS INFUSION TUBING HAD BECOME DISCONNECTED FROM THE INFUSION SITE. HE RECONNECTED AND BOLUSED. HE STATED THAT HE CONTINUES TO SMELL INSULIN BUT HE CANNOT FEEL OR SEE WHERE IT IS COMING FROM. HE ALSO REPORTED THAT HE WAS AWOKEN AT 4:00AM BY AN ALARM ON HIS INFUSION DEVICE. HE HAD PROGRAMMED THE AUTOMATIC OFF FOR 9 HOURS AND HE HAD NOT PRESSED ANY BUTTONS ON THE INFUSION DEVICE. HE IS UNSURE HOW LONG THE INFUSION DEVICE WAS IN THE STOP MODE. TO TROUBLESHOOT THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION SITE AND TO BOLUS. INSULIN FLOWED FROM THE END OF THE INFUSION TUBING WITHOUT ERROR. THE PATIENT WAS ADVISED TO CHANGE HIS INFUSION SITE. WHEN THE INFUSION SITE WAS REMOVED THE PATIENT STATED THAT HE WAS BLEEDING. UPON FOLLOW UP ON FIVE DAYS LATER, THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE WAS ELEVATED TO 232 MG/DL WHEN HE WOKE UP. HE STATED THAT HIS BLOOD GLUCOSE TYPICALLY FLUCTUATES. HE MET WITH A COMPANY REPRESENTATIVE ON THE DAY AFTER THE ORIGINAL DATE, AND BEGAN USING A DIFFERENT TYPE OF INFUSION SET. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 8A160UF

    Patients

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