BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7168542 · Received January 5, 2018

    Report

    Report Number
    3004464228-2018-00117
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    December 10, 2017
    Report Date
    December 11, 2017
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. LOT RELEASE AND STERILIZATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: UST400, 14421-AW REV H 01/16. LIVING WITH DIABETES 9 / PAGE 107: WARNING: IF AN INFUSION SITE SHOWS SIGNS OF INFECTION: 1. IMMEDIATELY REMOVE THE POD AND APPLY A NEW ONE AT A DIFFERENT SITE. 2. CONTACT YOUR HEALTHCARE PROVIDER. WARNING: CHECK THE SITE FOR SIGNS OF INFECTION, SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE OR HEAT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED AN INFECTION AT THE INSERTION SITE THAT WAS MAKING HIS HAND GO NUMB. HE WENT TO THE DOCTOR, WAS DIAGNOSED WITH (B)(6) CELLULITIS, AND PRESCRIBED A 7 DAY SUPPLY OF SULFAMETHOXAZOLE/TRIMETHOPRIM 800-150 MG. HIS BLOOD GLUCOSE HAD ALSO REACHED 437 MG/DL, BUT WENT BACK TO A NORMAL RANGE ONCE HE CHANGED THE POD. THE POD WAS WORN ON THE ARM FOR LONGER THAN 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11335 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L42938 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR