BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1911790 · Received November 24, 2010

    Report

    Report Number
    3004464228-2010-01395
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 28, 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 PDM INVOLVED WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PT CONFIRMED BG READINGS WITH ANOTHER DEVICE BEFORE TAKING ANY ACTION, PER USER INSTRUCTIONS. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. IT ALSO SUGGESTS THAT THE PT ALWAYS CARRY EXTRA SUPPLIES IN CASE OF EMERGENCY. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER SON WAS TRANSPORTED TO THE EMERGENCY ROOM BECAUSE, THE PDM "WAS GIVING ERRATIC BG READINGS" IN COMPARISON TO AN ALTERNATE METER. BG READINGS FORM THE PDM RANGED FROM 39-180MG/DL, WHILE READING FORM THE HOSPITAL'S METER RANGED FROM 169-319MG/DL. THE PDM WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11360 L12099

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention