BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1131937 · Received August 22, 2008

    Report

    Report Number
    2183996-2008-01273
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 25, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 07/25/2008, A COMPANY REP REPORTED THAT THE PT WAS EXPERIENCING BENDING OF THE INFUSION SET CANNULA AND PAIN UPON INSERTION. UPON FOLLOW UP WITH THE PT SHE STATED THAT SHE EXPERIENCES PAIN WHILE INSERTING THE INFUSION SITE INTO HER SKIN AND THE NEEDLES "FLEX" DURING INSERTION. SHE STATED SHE INSERTS THE INFUSION SITE AT A 30 DEGREE ANGLE AND SHE WAS ADVICED BY HER TRAINER TO INSERT THE INFUSION SITE AT A 45 DEGREE ANGLE. SHE STATED THAT DUE TO THE ISSUE HER BLOOD GLUCOSE ELEVATED TO 250 MG/DL. HER NORMAL BLOOD GLUCOSE LEVEL IS 150 MG/DL OR LESS. SHE WAS ABLE TO BOLUS TO LOWER HER BLOOD GLUCOSE. THE PT ALSO REPORTED THAT SHE IS TAKING PREDNISONE FOR INFLAMMATION WHICH MAY HAVE CAUSED ELEVATED READINGS. SHE WAS SENT SAMPLE INFUSION SETS AND AN INSERTION DEVICE. FURTHER ATTEMPTS TO FOLLOW UP WITH THE PT WERE UNSUCCESSFUL. 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 TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS, INC. NA 598205

    Patients

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