BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3964008 · Received July 9, 2014

    Report

    Report Number
    3004464228-2014-00976
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    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 PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT FOR HYPOGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    TIME: 12:56 AM, BLOOD GLUCOSE (MG/DL): 45; TIME: 1:26 AM, BLOOD GLUCOSE (MG/DL): 67; TIME: 3:32 AM, BLOOD GLUCOSE (MG/DL): 464, BOLUS (UNITS), 6.45U. THE CUSTOMER REPORTED THAT HER PDM HAD RESET EARLIER IN THE DAY AND THAT HER BOLUS CALCULATOR WAS ON A DELAY. SHE MANUALLY ENTERED A BOLUS FOR HER 454 MG/DL READING, AND SHE BELIEVES THAT SHE OVER BOLUS BECAUSE HER SON FOUND HER INCOHERENT AND TOOK HER TO THE ER. SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND LOW BLOOD PRESSURE AND WAS TREATED WITH AN IV. SHE WAS IN THE HOSPITAL FOR ABOUT 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402166 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 1400 L40865

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization