BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDER INFUSION SET

    MDR report key: 969808 · Received December 21, 2007

    Report

    Report Number
    2183996-2007-01870
    Event Type
    Injury
    Date Received
    December 21, 2007
    Date of Event
    December 16, 2007
    Report Date
    December 16, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL A/S, AHOLMVEJ 1, OSTED 4000 ROSKILDE.

    Description of Event or Problem · 1

    IN 2007, THE PATIENT STATED THAT SHE RECEIVED AN 04 (OCCLUSION) ERROR ON HER INFUSION DEVICE WHILE TRYING TO BOLUS AND HER BLOOD GLUCOSE WAS ELEVATED TO 345 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 80-140 MG/DL. TO TROUBLESHOOT THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE AND SHE WAS ABLE TO BOLUS WITHOUT ERROR. SHE WAS ADVISED TO CHANGE HER INFUSION SITE AND SHE STATED THE CANNULA WAS BENT. THE INFUSION SITE HAD BEEN IN USE FOR 1 DAY. THE PATIENT WAS OUT OF INFUSION SITES AND SWITCHED TO INJECTION THERAPY TO LOWER HER BLOOD GLUCOSE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDER INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA 688695

    Patients

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