BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2220184 · Received August 16, 2011

    Report

    Report Number
    3004464228-2011-00423
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND NO EVIDENCE OF ANY MFG DEFECT WAS DEFECTED. THE LAB WAS FOUND NO EVIDENCE OF "AN ODD BEND IN THE CANNULA" AS "FLUID WAS OBSERVED EXITING THE CANNULA INDICATING NO INTERNAL OCCLUSION," HOWEVER, LAB TESTS DID NOT FIND AN AIR BUBBLE, EQUIVALENT TO 5 TO 6 UNITS OF INSULIN SIZE, IN THE DEVICE'S INSULIN RESERVOIR. THIS USUALLY OCCURS DURING THE FILL PROCESS AND IS DUE TO USER ERROR AND IS NOT A CAUSE OF PRODUCT MALFUNCTION OR DEFECT. USER ERROR IS CONFIRMED AS HAVING CAUSED THE POD TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION. THE OMNIPOD USER'S GUIDE INSTRUCTS USER ON PROPER FILLING TECHNIQUE AND WARNS TO, "NEVER INJECT AIR INTO THE FILL PORT. DOING SO MAY RESULT IN UNINTENDED OR INTERRUPTED INSULIN DELIVERY." INTERRUPTED INSULIN DELIVERY HAS THE POTENTIAL TO RESULT IN HIGH BLOOD GLUCOSE LEVELS. INSULET HAS INITIATED AN INTERNAL INVESTIGATION TO DETERMINE IF EDUCATION AND TRAINING RELATED TO THIS TOPIC CAN BE IMPROVED. THE INVESTIGATION IS IN-PROCESS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ON (B)96) 2011 AT 6:00PM, THE CUSTOMER ACTIVATED A NEW POD. LATER THAT NIGHT HE BEGAN EXPERIENCING HIGH BLOOD GLUCOSE (BG) LEVELS; AT 11:00PM, HIS BG WAS 192MG/DL. HIS BG CONTINUED TO RISE, AT 3:00AM, IT READ 264MG/DL AND AT 6:30AM, HIS BG HAD REACHED 400MG/DL. AT THAT TIME, HE ADMINISTERED A BOLUS OF INSULIN OF 10 UNITS. WHILE ADMINISTERING THE BOLUS DOSE OF INSULIN, THE CUSTOMER NOTICED "AN ODD BEND IN THE CANNULA." THE PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30507

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR