BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3881287 · Received February 18, 2014

    Report

    Report Number
    3004464228-2014-00192
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED BENT CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2014 HER BLOOD GLUCOSE AND INSULIN HISTORY (EXACT TIME WAS NOT PROVIDED) IS AS FOLLOWS: BG (MMOL/L): 8.6, (MG/DL): 155. BG (MMOL/L): 18.0, (MG/DL): 324. BOLUS (U): BOLUS (EXACT DOSAGE WAS NOT PROVIDED). ABOUT TWO HOURS LATER, HER BG WAS STILL HIGH (EXACT BG LEVEL WAS NOT PROVIDED). SHE DECIDED TO REMOVE THE POD AND THEN SHE NOTICED THE CANNULA LOOKS LIKE ITS BENDING TOWARD THE INSIDE OF THE POD. SHE WAS ABLE TO LOWER HER BG TO 9.6 MMOL/L (173 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100923 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40730

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR