BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1031270 · Received April 18, 2008

    Report

    Report Number
    2183996-2008-00560
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 10, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED HIS INSULIN INFUSION SET "PULLED APART" WHILE HE WAS WEARING IT AND HE EXPERIENCED A BLOOD GLUCOSE READING OF "HI." HE STATED THE CANNULA PUSHED UP OUT OF HIS SKIN AND PARTIALLY PROTRUDED OUT OF THE ADHESIVE. HE SAID HE HAD WORN THE INFUSION SET FOR 2 DAYS WHEN THE INCIDENT HAPPENED. HE STATED HE CORRECTED HIS READING BY CHANGING HIS INFUSION SET AND TAKING A WALK. DURING TROUBLESHOOTING, THE PT STATED HE INSERTED HIS INFUSION SET AT A 90 DEGREE ANGLE. THE PT WAS ADVISED HE SHOULD INSERT THIS TYPE OF INFUSION SET AT A 20-45 DEGREE ANGLE AS RECOMMENDED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS NA 591844

    Patients

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