BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3122533 · Received May 16, 2013

    Report

    Report Number
    3004464228-2013-00455
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    February 4, 2013
    Report Date
    April 16, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO INFORMATION ABOUT THE REASON FOR THE PATIENT'S HOSPITALIZATION, NOR ABOUT HER DIABETES CARE LEADING UP TO HER ADMISSION, WAS REPORTED. WE ARE UNABLE TO DETERMINE IF THE DEVICE COULD HAVE CONTRIBUTED. NO QUALIFICATION RECORDS WERE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS PROVIDED. NO LABELING REVIEW WAS PERFORMED BECAUSE NO INFORMATION ABOUT THE PATIENT'S CONDITION OR ABOUT ANY POSSIBLE DEVICE MALFUNCTION WAS PROVIDED.

    Description of Event or Problem · 1

    (B)(6), A SOCIAL WORKER WITH (B)(6) MEDICAL CENTER IN (B)(6), REPORTED ON (B)(6) THAT AN OMNIPOD PATIENT WHO WAS CURRENTLY IN THE ICU WITH DKA HAD ALSO BEEN ADMITTED TO THE HOSPITAL ON (B)(6). THREE ATTEMPTS WERE MADE TO REACH THE PATIENT AND OBTAIN ADDITIONAL INFORMATION ABOUT THIS EVENT. SHE DID NOT RESPOND TO MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217875 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization