BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3980944 · Received July 22, 2014

    Report

    Report Number
    3004464228-2014-01030
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE AE UNABLE TO DETERMINE IF ANY PRODUCT MALFUNCTION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT'S FATHER REPORTED HIS DAUGHTER'S BLOOD GLUCOSE REACHED 400 MG/DL LESS THAN 24 HOURS AFTER THE POD WAS ACTIVATED. THEY TRIED TO GIVE A CORRECTIONAL BOLUS BUT HE WAS NOT ABLE TO PROGRAM THE BOLUS WITH THE PDM AT THE TIME. HE TOOK HER TO THE HOSPITAL AND UPON ARRIVAL THEY PLACED HER ON AN INTRAVENOUS THERAPY. THEY ALSO GAVE HER A MANUAL INJECTION OF 7.0 UNITS OF INSULIN AND ANOTHER 4.0 UNITS 2 HOURS LATER. THE POD WAS REMOVED AND DISCARDED. HER BG READING WAS COMING DOWN FROM 430 MG/DL TO 235 MG/DL AND LATER TO 180 MG/DL. THE NEXT DAY SHE WOKE UP WITH BG READING OF 80 MG/DL. SHE WAS ABLE TO ACTIVATE A NEW POD AND HER BG LEVEL WAS GOOD AT THE TIME OF THE CALL. EVERY TIME THE PDM DOES A BOLUS CALCULATION THEY WOULD HAVE TO MANUALLY CALCULATE THE PROPER DOSAGE AND OVERRIDE THE CALCULATED BOLUS AND ENTER THE CORRECT DOSAGE INTO THE PDM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429383 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14500-5A L60118

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization