BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1213510 · Received October 27, 2008

    Report

    Report Number
    2183996-2008-01624
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT ABOUT A MONTH AGO HIS BLOOD GLUCOSE ELEVATED TO 500 MG/DL DUE TO HIS SEVERE SCAR TISSUE. HE STATED HIS NORMAL RANGE IS 80-250 MG/DL. HE SAID HE EXPERIENCED LEG CRAMPS AND CORRECTED HIS READING BY INJECTING 8 UNITS OF INSULIN. HE STATED HIS INSULIN INFUSION HEADSET WAS NOT KINKED OR BENT WHEN HE REMOVED IT AND THERE WAS NO INSULIN LEAKING FROM HIS INFUSION SITE. HE SAID THERE WAS NO AIR BUBBLES IN THE INFUSION SET TUBING OR THE INSULIN CARTRIDGE OF HIS INFUSION DEVICE. SITE ROTATION AND MANAGEMENT WERE DISCUSSED WITH THE PATIENT AND A COURTESY GUIDE TO INFUSION SITE MANAGEMENT AND SAMPLE INFUSION SETS WERE SENT TO THE PATIENT. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

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