BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3851258 · Received March 26, 2014

    Report

    Report Number
    3004464228-2014-00378
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 24, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT 6:00 PM ON (B)(6) 2014, HIS BLOOD GLUCOSE (BG) READING WAS 85 MG/DL, AND HE GAVE HIMSELF A 2.8 UNIT BOLUS. AT 9:30 PM, HIS BGS HAD RISEN TO 284 MG/DL. WHEN THE POD WAS REMOVED, HE NOTICED THAT THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176758 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 1400 L40498

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR