BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3230992 · Received July 17, 2013

    Report

    Report Number
    2183996-2013-01313
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    August 30, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED USED HEADSET. IN THE VISUAL INSPECTION FOUND THE SOFT CANNULA WAS KINKED. THERE IS NO INDICATION THAT A NONSPECIFIC PRODUCT HAD BEEN DELIVERED TO THE CUSTOMER. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO A MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED HIS BLOOD GLUCOSE WAS ELEVATED OVER 500 MG/DL AND HE WAS VOMITING. HE DROVE HIMSELF TO THE HOSPITAL WHERE HE WAS TREATED WITH AN IV OF SALINE FLUIDS AND INSULIN. THE PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 100-180 MG/DL. THE PATIENT ATTEMPTED TO SELF-TREAT AT HOME BEFORE GOING TO THE HOSPITAL. HE STATED WHEN HE REMOVED THE INFUSION SET HE CANNULA WAS BENT. HE HAD BEEN USING THE INFUSION SET FOR ABOUT 19 HOURS. HE INSERTED ANOTHER INFUSION SET AFTER HIS BLOOD GLUCOSE LEVELS BEGAN TO RISE AND WHEN HE REMOVED THAT INFUSION SET HE FOUND THAT CANNULA WAS ALSO BENT. THE PATIENT STATED THAT THERE WERE NO INSULIN LEAKS. THE INFUSION SETS AND INSERTION DEVICE WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330537 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC NA 5016692

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR Hospitalization| R NOVOLOG| LISINIPRIL