BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3122512 · Received May 15, 2013

    Report

    Report Number
    3004464228-2013-00442
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 17, 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. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR HYPOGLYCEMIA. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE 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 PATIENT CALLED TO REPORT THAT SHE WAS HOSPITALIZED FOR HYPOGLYCEMIA ON APPROXIMATELY (B)(6) 2013. SHE STATED THAT SHE WAS UNCONSCIOUS AND TAKEN TO THE HOSPITAL BY AMBULANCE. SHE SAID THAT SHE HAD ISSUES WITH POD INSULIN DELIVERY. HER RESULT WITH THE HOSPITAL METER WAS 20 MG/DL WHILE HER PDM RESULT WAS 80 MG/DL. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION. SHE RETURNED ONE CALL, BUT WAS NOT INTERESTED IN PROVIDING FURTHER INFORMATION. ADDITIONAL ATTEMPTS MADE TO CONTACT HER WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214674 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR