BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2200768 · Received July 28, 2011

    Report

    Report Number
    3004464228-2011-00388
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 27, 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 PRODUCT WAS DISCARDED AND WILL NOT BE RETURNING FOR EVAL. UNABLE TO DETERMINE IF A MALFUNCTION OCCURRED THAT WOULD HAVE CONTRIBUTED TO THE PT'S "HIGH" BLOOD GLUCOSE LEVEL. UNABLE TO CONFIRM THAT THE PT'S REPORTED "SILENT HEART ATTACK" WAS RELATED TO HER DIABETES. THE USER GUIDE EMPHASIZES TO CHECK BLOOD GLUCOSE FREQUENTLY TO DETECT AND RESPOND TO HIGH AND LOW BLOOD GLUCOSE PROMPTLY. THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT SHE WENT TO THE HOSPITAL ON (B)(6) 2011 WITH A "HIGH" BLOOD GLUCOSE READING. NO SPECIFIC VALUES WERE REPORTED. THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO A "SILENT HEART ATTACK." CUSTOMER WAS RELEASED FROM THE HOSPITAL AND IS DOING WELL WITH A BLOOD GLUCOSE OF 87 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30512

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization