BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1202821 · Received October 14, 2008

    Report

    Report Number
    2183996-2008-01584
    Event Type
    Injury
    Date Received
    October 14, 2008
    Date of Event
    October 3, 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
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HE REC'D AN E8 (POWER INTERRUPT) ERROR ON HIS INSULIN INFUSION DEVICE. THE PT WAS ASSISTED IN CLEARING IT AND STATED HE REC'D IT BECAUSE HE REMOVED THE BATTERY DUE TO GETTING AN E4 (OCCLUSION) MESSAGE THAT HE DID NOT KNOW HOW TO CLEAR. HE STATED HE FIRST GOT AN E4 WHEN HE TRIED TO BOLUS FOR ELEVATED READINGS. HE SAID HE CHANGED HIS TUBING AND TRIED AGAIN TO BOLUS, BUT RECEIVED ANOTHER E4. HE STATED HIS BLOOD GLUCOSE READING WAS 426 MG/DL WITH IS NORMAL RANGE BEING AROUND 130 MG/DL. HIS SYMPTOM WAS FEELING CONFUSED. THE PT WAS INSTRUCTED TO RUN A PRIME AND HE REC'D A OTHER E4 MESSAGE. HE WAS THEN INSTRUCTED TO DISCONNECT THE TUBING AND PRIME THROUGH THE ADAPTER WHICH HE DID WITHOUT ERROR. THE PT WAS INSTRUCTED TO ATTACH A NEW TUBING AND HE SUCCESSFULLY RAN A PRIME THROUGH IT. THE PT SUCCESSFULLY DELIVERED A 5 UNIT BOLUS OF INSULIN TO TREAT HIS ELEVATED READING. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO A ADDRESS THE ISSUE. PRODUCT 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 8E101UF

    Patients

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