BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3894001 · Received June 17, 2014

    Report

    Report Number
    3004464228-2014-00829
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 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 ARE UNABLE TO DETERMINE IF ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PATIENT'S KETOACIDOSIS AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE WAS HOSPITALIZED WITH KETOACIDOSIS AND SICKNESS. SHE ALSO STATED THAT SHE GAVE HERSELF A BOLUS OF INSULIN BUT LOOKING IN THE PDM THERE WAS NO BOLUS REGISTERED IN THE HISTORY. SHE DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THE HOSPITALIZATION OR HER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356207 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14500-5E L60065

    Patients

    Seq Age Sex Outcome Treatment
    1 114 YR Hospitalization