BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4232596 · Received September 11, 2014

    Report

    Report Number
    3004464228-2014-01350
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 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 NEEDLE MECHANISM FAILURE (TO RETRACT), TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA, OR TO DETERMINE THE ROOT CAUSE. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE HISTORY IS AS FOLLOWS: SHE NOTICED THE NEEDLE NEVER RETRACT BACK INTO THE POD. THE CANNULA WAS DARK AND WHEN SHE "FLICKED" THE POD THE NEEDLE MECHANISM FINALLY MOVED BACK INTO THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563078 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41166

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR