BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3883181 · Received February 20, 2014

    Report

    Report Number
    3004464228-2014-00210
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 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 HAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE FAILURE OF THE NEEDLE MECHANISM TO RETRACT, TO DETERMINE ANY ROOT CAUSE, OR TO DETERMINE IF IT COULD HAVE 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 THAT HER BLOOD GLUCOSE REACHED 20.6 MMOL/L (371 MG/DL) 14 HOURS AFTER THE DEVICE WAS ACTIVATED AND THAT THE NEEDLE DID NOT RETRACT PROPERLY AFTER THE CANNULA WAS DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108417 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5E L40750

    Patients

    Seq Age Sex Outcome Treatment
    1