BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1001022 · Received February 20, 2008

    Report

    Report Number
    2183996-2008-00187
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE RECEIVED AN OCCLUSION (E4) ERROR WHILE ATTEMPTING TO BOLUS 7 UNITS OF INSULIN AND HER BLOOD GLUCOSE WAS ELEVATED TO 455 MG/DL AND SHE FELT VERY TIRED. TO TROUBLESHOOT THE PT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE AND TO PERFORM A PRIME. THE PRIME WAS COMPLETED SUCCESSFULLY. THE PT WAS THEN INSTRUCTED TO PERFORM A 1 UNIT BOLUS. THE BOLUS COMPLETED SUCCESSFULLY. THE PT STATED THAT THE INFUSION SITE HAD BEEN IN PLACE FOR "APPROX 2 DAYS OR IT COULD BE A LITTLE LONGER." THE PT WAS ADVISED TO CHANGE THE INFUSION SITE EVERY 3 DAYS. SHE REMOVED THE INFUSION SITE AND THE CANNULA WAS BENT. THE PT INSERTED A NEW INFUSION SITE AND SHE WAS ABLE TO BOLUS WITHOUT ERROR. UPON FOLLOW UP ON FOUR DAYS LATER, THE PT STATED HER BLOOD GLUCOSE HAD RETURNED TO THE NORMAL RANGE (100 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 EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET LZG DISETRONIC MEDICAL SYSTEMS NA 7E243UF

    Patients

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