BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1030017 · Received April 14, 2008

    Report

    Report Number
    2183996-2008-00524
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K033892
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED SHE HAS BEEN EXPERIENCING REPEATED E4 (OCCLUSION) ERRORS ON HER INFUSION DEVICE DUE TO HER INFUSION TUBING. THE INFUSION TUBING HAS BEEN IN USE FOR ALMOST 24 HRS. SHE STATED THAT SHE CHANGED THE INFUSION THE PREVIOUS NIGHT. SHE STATED THAT SHE PERFORMED A 4 UNIT BOLUS IN THE AIR AND REC'D AN E4. SHE THEN REMOVED THE INFUSION TUBING FROM THE INFUSION DEVICE AND WAS ABLE TO BOLUS WITHOUT ERROR. THE FOLLOWIG MONTH, THE PT REPORTED THAT HER BLOOD GLUCOSE WAS ELEVATED TO 400-500 MG/DL DUE TO THE OCCUSION ERRORS. HER NORMAL BLOOD GLUCOSE RANGE IN 150-160 MG/DL. TO LOWER HER BLOOD GLUCOSE SHE INJECTED INSULIN VIA SYRINGE. SHE STATED THAT SHE BELIEVES HER INSULIN WAS THE CAUSE OF THE OCCLUSIONS BECAUSE IT WAS CRYSTALIZED IN SOME OF THE INFUSION TUBINGS. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD 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 6K107UF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INSULIN INFUSION PUMP| INSULIN