BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3964020 · Received May 22, 2014

    Report

    Report Number
    3004464228-2014-00697
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 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

    TIME: (B)(6) 2014, TIME: 10:13 A.M., BLOOD GLUCOSE (MMOL/L) 11.5 (207 MG/DL) - ATE 26G CARBS. TIME: 1:00 P.M., BLOOD GLUCOSE (MMOL/L) 22.0 (396 MG/DL) - DEACTIVATED POD. THE CUSTOMER REPORTED THAT WHEN SHE REMOVED THE POD, SHE NOTICED THAT THE CANNULA WAS A LITTLE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306654 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40730

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR