BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2974130 · Received February 13, 2013

    Report

    Report Number
    3004464228-2013-00116
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 14, 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

    NO PRODUCT WAS RETURNED FOR EVALUATION. UNABLE TO CONFIRM ANY MALFUNCTION OR OTHER PRODUCT CONDITION THAT MAY HAVE CONTRIBUTED TO THE REPORTED HYPOGLYCEMIA. THERE ARE SAFETY MECHANISMS IN THE DESIGN OF THE POD TO PREVENT OVER-DELIVERY OF INSULIN THAT CONTRIBUTED TO LOW BLOOD GLUCOSE. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS THE CUSTOMER DID NOT PROVIDE A PRODUCT LOT NUMBER. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." IT ALSO WARNS, "EVEN IF YOU CANNOT CHECK YOUR BLOOD GLUCOSE, DO NOT WAIT TO TREAT SYMPTOMS OF HYPOGLYCEMIA, ESPECIALLY IF YOU ARE ALONE. WAITING TO TREAT SYMPTOMS COULD LEAD TO SEVERE HYPOGLYCEMIA, WHICH CAN QUICKLY LEAD TO SHOCK, COMA, OR DEATH."

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED THAT HER MOTHER WAS AT HER SISTER'S HOUSE WHEN SHE COLLAPSED. SHE WAS TAKEN BY AMBULANCE TO THE HOSPITAL, WHERE SHE WAS ADMITTED. HER BLOOD GLUCOSE WAS LOW. SPECIFIC READINGS WERE NOT AVAILABLE AS SHE STATED THAT IT WAS LIKELY CHECKED IN THE AMBULANCE USING A BLOOD GLUCOSE METER. THE CUSTOMER'S DAUGHTER DID NOT KNOW WHAT WAS ADMINISTERED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64331 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization