BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1893434 · Received November 5, 2010

    Report

    Report Number
    3004464228-2010-01350
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 8, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD INVOLVED WILL NOT BE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE OMNIPOD USER GUIDE INSTRUCTS USERS TO CHECK BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY'RE ABLE TO NOTICE AND REACT QUICKLY AND APPROPRIATELY TO HIGH BG LEVELS. THE USER GUIDE ALSO SUGGESTS THAT THE PT ALWAYS CARRY EXTRA SUPPLIES IN CASE OF AN EMERGENCY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAD TO GO TO THE ER AS A RESULT OF HIGH BG READINGS (GREATER THAN 500MG/DL) WITH SMALL KETONES. DESPITE HAVING ADMINISTERED "SEVERAL BOLUSES", HER BG LEVELS REMAINED HIGH. NO INFO ABOUT THE TREATMENT RECEIVED OR HER STAY AT THE HOSPITAL WAS PROVIDED. ADDITIONALLY, NO SPECIFIC DEVICE FAILURE WAS CITED. THE POD WAS DISCARDED IN THE ER AND WILL, THEREFORE, NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30128

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention