BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4093025 · Received September 8, 2014

    Report

    Report Number
    3004464228-2014-01335
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 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 RETURNED DEVICE WAS EVALUATED AND THE INVESTIGATION RESULTS FOUND NO DEFECTS OR DEFICIENCIES THAT WOULD RESULT IN THE CANNULA FAILING TO INSERT CORRECTLY. HOWEVER, THE INVESTIGATION DID FIND EVIDENCE OF AN INTERNAL LEAK. ITS ROOT CAUSE WAS DETERMINED TO BE A DAMAGED CANNULA. THE DAMAGE APPEARED TO HAVE OCCURRED DURING THE MFG PROCESS. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    TIME: 7:30PM; BLOOD GLUCOSE (MG/DL): 300; BOLUS (UNITS): 9.00U. TIME: 9:30PM; BLOOD GLUCOSE (MG/DL): 400; BOLUS (UNIT: 10.00U; TIME: 10:30PM- POD DEACTIVATED. THE CUSTOMER DOES NOT THINK CANNULA WAS INSERTED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551055 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40496

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR