BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4036737 · Received August 21, 2014

    Report

    Report Number
    3004464228-2014-01220
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 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 CONFIRM ANY PRODUCT MALFUNCTION TO HAVE CONTRIBUTED TO THE PT'S KETOACIDOSIS AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PT REPORTED THAT ON (B)(6) 2014 SHE RECEIVED A PDM HAZARD ALARM AND DID NOT KNOW WHAT WAS GOING ON SO SHE DECIDED TO GO (B)(6). UPON ARRIVAL SHE WAS ADMITTED WITH DIABETIC KETOACIDOSIS (DUE TO INSULIN PUMP FAILURE PER THE DOCTOR) AND HER BLOOD GLUCOSE (LAB) RESULTS WERE 486 MG/DL. THEY PLACED HER ON AN INSULIN DRIP AND ONCE THE PDM ERROR WAS CLEARED THEY WERE ABLE TO ACTIVATE A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505751 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14500-5A L60123

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization