BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3233644 · Received July 18, 2013

    Report

    Report Number
    2183996-2013-01318
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 26, 2013
    Report Date
    July 24, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE, THE COMPLAINT CANNOT BE VERIFIED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO PRODUCT AVAILABLE TO BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S MOTHER REPORTED THAT HE WAS IN THE HOSPITAL WITH DIABETIC KETOACIDOSIS ON (B)(6) 2013. HIS MOTHER STATED THAT HE WAS GETTING REPEATED OCCLUSIONS AND WHEN SHE WOULD REMOVE THE INFUSION SET IT APPEARED THAT THE CANNULA WAS BENT. SHE INSERTS THE INFUSION SET INTO THE MUSCLE OF HIS ARM. BEFORE HE WENT TO THE HOSPITAL, HIS BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. AT THE HOSPITAL IT WAS BETWEEN 620- 640 MG/DL. HIS NORMAL RANGE IS 80-140 MG/DL DURING THE DAY AND OVER 400 MG/DL AT NIGHT. HE WAS TREATED WITH AN IV OF FLUIDS AND INSULIN AT THE HOSPITAL. THE PATIENT CONTINUES TO USE THE INFUSION DEVICE AND HIS BLOOD GLUCOSE LEVELS HAVE RETURNED TO NORMAL. THE PATIENT SWITCHED TO A DIFFERENT INFUSION SET AND HAS NOT HAD ANY FURTHER PROBLEMS. THE INFUSION SETS WERE DISCARDED; THEREFORE THEY ARE UNABLE TO BE REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333258 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 010 YR Hospitalization| R LANTUS| NOVOLOG