BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3963855 · Received May 20, 2014

    Report

    Report Number
    3004464228-2014-00683
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 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 THE POD WAS ACTIVATED AT 10:17PM ON (B)(6) 2014. AT 10:42PM, HER BLOOD GLUCOSE WAS 183 MG/DL, SO SHE TOOK A 0.65U BOLUS. THE CUSTOMER WOKE UP AT 1:35AM ON (B)(6) 2014 BECAUSE SHE FELT "SICK TO HER STOMACH". WHEN SHE CHECKED HER BLOOD GLUCOSE, SHE NOTICED THAT HER BGS HAD RISEN TO 316 MG/DL, SO SHE REMOVED THE POD. WHEN THE POD WAS REMOVED, THE CUSTOMER NOTICED THAT THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298565 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40887

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR