BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4202251 · Received October 15, 2014

    Report

    Report Number
    3004464228-2014-01548
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 18, 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 EVAL. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND HOSPITALIZATION. NOT PRODUCT LOT NUMBER WAS REPORTED THEREFORE, NO QUALIFICATION RECORDS WERE REVIEWED.

    Description of Event or Problem · 1

    AN (B)(6) REP REPORTED THAT ON (B)(6) 2014 AN (B)(6) BOY WOKE UP WITH THE POD ALARMING FOR NO INSULIN SUPPLY AND THE POD WAS REMOVED. HE GAVE HIMSELF A MANUAL INJECTION, WITH AN INSULIN PEN (EXACT DOSAGE WAS NOT PROVIDED) AND WAS ABLE TO ACTIVATE A NEW POD. HE WAS WORRIED THAT HE WAS GOING INTO DIABETIC KETOACIDOSIS SO HE DECIDED TO GO TO THE HOSPITAL AND UPON ARRIVAL, HE WAS NOT DIAGNOSED WITH DKA. HE HAS BEEN POORLY MANAGING HIS BLOOD GLUCOSE AND HAS STRUGGLED WITH BEING INSULIN RESISTANT. HE DID NOT PROVIDE ANY FURTHER INFO REGARDING THE HOSPITALIZATION, BG HISTORY OR HIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654374 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization