BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2002368 · Received February 16, 2011

    Report

    Report Number
    3004464228-2011-00070
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    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 WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY MALFUNCTION OF THE DEVICE THAT MAY HAVE RESULTED IN ERRONEOUS OR FALSE-HIGH BG READINGS. 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 PATIENT ALWAYS CARRY EXTRA SUPPLIES IN CASE OF ANY EMERGENCY. THE CUSTOMER PROPERLY FOLLOWED USER GUIDE INSTRUCTION BY SEEKING MEDICAL ATTENTION IN ORDER TO TREAT HER HIGH BLOOD GLUCOSE LEVELS. WITHOUT THE PDM RETURNED FOR EVALUATION, WE ARE UNABLE TO DETERMINE WHETHER THE DEVICE WAS A CONTRIBUTING FACTOR TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER HAD EXPERIENCED HIGH BG LEVELS AND, AS A RESULT, EMS HAD TO BE CALLED. (BG READINGS THAT WERE PROVIDED RANGED FROM 257-336 MG/DL, THOUGH NO TIME LINE OF THESE READINGS WAS INDICATED.) THE OTHER BELIEVED THAT THE BG METER WAS NOT WORKING PROPERLY (DUE TO THE FACT THAT SHE "WENT THROUGH SIX STRIPS" WHEN TAKING READINGS). THE CUSTOMER WAS TREATED BY THE EMS; SHE WAS NOT TAKEN TO THE HOSPITAL. THE PDM WILL NOT 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 13100-2B UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention